Zimmer Biomet, Inc.: FDA recalls

FDA enforcement reports name Zimmer Biomet, Inc. as the recalling firm in 144 events. The events have 875 product records. The recalls started from 2012 to 2020. All the events are device recalls.

See the 144 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

144 events, newest first.

FDA enforcement events of Zimmer Biomet, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
20 Nov 2020	Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.	Device	Class II	1	Terminated
17 Nov 2020	Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system	Device	Class II	1	Terminated
24 Sep 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 43mm Item Number: 00-8065-540-22 Hip prosthesis component	Device	Class II	75	Terminated
14 Aug 2020	Dual Mobility Vivacit-E Bearing, Model Number 110031009	Device	Class II	1	Terminated
5 May 2020	Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and…	Device	Class II	25	Terminated
7 Jan 2020	THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.	Device	Class II	1	Terminated
23 Dec 2019	Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00	Device	Class II	1	Terminated
19 Dec 2019	ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument	Device	Class II	1	Terminated
12 Dec 2019	Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.	Device	Class II	1	Terminated
25 Oct 2019	Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660	Device	Class II	2	Terminated
10 Oct 2019	BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 00430001420 00430001513 00430001613 00430001713 00430001813…	Device	Class II	41	Terminated
21 Aug 2019	Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733…	Device	Class II	15	Terminated
15 Aug 2019	XP- CR Tibial Tray- Interlok 59mm Item # 195268	Device	Class II	35	Terminated
6 Aug 2019	ASI 2.0 Calcar Trimmer Shaft for Use with Biomet Rasp, Model Number 110032331	Device	Class II	1	Terminated
2 Jul 2019	Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810	Device	Class II	6	Terminated
10 Jun 2019	Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509	Device	Class II	2	Terminated
4 Jun 2019	Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.	Device	Class II	2	Terminated
28 May 2019	DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.	Device	Class II	3	Terminated
18 Apr 2019	Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small	Device	Class II	6	Terminated
1 Apr 2019	Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc…	Device	Class II	1	Terminated
28 Mar 2019	T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges,…	Device	Class II	2	Terminated
1 Mar 2019	Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant	Device	Class II	2	Terminated
28 Feb 2019	Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989	Device	Class II	1	Terminated
21 Dec 2018	Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint…	Device	Class II	1	Terminated
21 Dec 2018	Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764	Device	Class II	2	Terminated
28 Nov 2018	Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals	Device	Class II	2	Terminated
20 Nov 2018	Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula…	Device	Class II	2	Terminated
14 Nov 2018	Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to restore the integrity of the spinal column…	Device	Class II	1	Terminated
31 Oct 2018	NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.	Device	Class II	1	Terminated
24 Oct 2018	Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma.…	Device	Class II	1	Terminated
22 Oct 2018	Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.	Device	Class II	13	Terminated
22 Oct 2018	Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126	Device	Class II	2	Terminated
12 Oct 2018	Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537 Compress Device Centering Sleeve 15mm 178541…	Device	Class II	1	Terminated
10 Oct 2018	Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394	Device	Class II	2	Terminated
2 Oct 2018	Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.	Device	Class II	8	Terminated
21 Sep 2018	StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent, by injecting with a…	Device	Class II	1	Terminated
22 Aug 2018	Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.	Device	Class II	6	Terminated
8 Aug 2018	Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures	Device	Class II	48	Terminated
3 Aug 2018	Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992	Device	Class II	1	Terminated
2 Aug 2018	Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty	Device	Class II	2	Terminated
30 Jul 2018	Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal,…	Device	Class II	1	Terminated
20 Jul 2018	Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612	Device	Class II	2	Terminated
17 Jul 2018	Affixus Hip Fracture Nail Right 125¿ 9 mm x 280 mm, Item Number: 814309280	Device	Class II	129	Terminated
12 Jul 2018	Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot,…	Device	Class II	1	Terminated
22 Jun 2018	Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures	Device	Class II	1	Terminated
18 Jun 2018	Connecting Bolt, Model 14-442093	Device	Class II	1	Terminated
8 Jun 2018	ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.	Device	Class II	2	Terminated
30 May 2018	Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40	Device	Class II	15	Terminated
24 May 2018	Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.	Device	Class II	1	Terminated
18 May 2018	Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty	Device	Class II	1	Terminated
16 May 2018	DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.	Device	Class II	13	Terminated
11 May 2018	Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.	Device	Class II	1	Terminated
5 Apr 2018	Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.	Device	Class II	1	Terminated
3 Apr 2018	Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.	Device	Class II	1	Terminated
2 Apr 2018	Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.	Device	Class II	2	Terminated
29 Mar 2018	Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.	Device	Class II	1	Terminated
28 Mar 2018	Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.	Device	Class II	6	Terminated
26 Mar 2018	M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00	Device	Class II	12	Terminated
12 Mar 2018	Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S	Device	Class II	1	Terminated
1 Mar 2018	Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40	Device	Class II	2	Terminated
19 Feb 2018	EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.	Device	Class I	2	Terminated
6 Feb 2018	AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X30.0 - STERILE 800508315 NAIL TIB DYN 08X31.5 - STERILE 800508330 NAIL TIB DYN 08X33.0 - STERILE…	Device	Class II	2	Terminated
24 Jan 2018	Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)	Device	Class II	1	Terminated
3 Jan 2018	Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)	Device	Class II	1	Terminated
20 Dec 2017	ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur…	Device	Class II	11	Terminated
12 Dec 2017	PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.	Device	Class II	1	Terminated
8 Dec 2017	Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty	Device	Class II	2	Terminated
7 Dec 2017	6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis, Pediatric femoral neck fractures, Tibial…	Device	Class II	1	Terminated
29 Nov 2017	Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14 A spacer block is used to ensure the tibial…	Device	Class II	1	Terminated
29 Nov 2017	BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement	Device	Class II	48	Terminated
25 Oct 2017	A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403	Device	Class II	1	Terminated
25 Oct 2017	fastener, fixation, nondegradable, soft tissue	Device	Class II	1	Terminated
24 Oct 2017	Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery	Device	Class II	1	Terminated
11 Oct 2017	TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.	Device	Class II	2	Terminated
3 Oct 2017	Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04	Device	Class II	2	Terminated
3 Oct 2017	Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty	Device	Class II	1	Terminated
29 Sep 2017	Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty	Device	Class II	2	Terminated
15 Sep 2017	36MM COCR MODULAR HD -6MM	Device	Class II	1	Terminated
13 Sep 2017	Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument	Device	Class II	3	Terminated
11 Sep 2017	BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131	Device	Class II	1	Terminated
7 Sep 2017	The 2nd Assist Knee Positioner	Device	Class II	1	Terminated
28 Aug 2017	Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.	Device	Class II	1	Terminated
25 Aug 2017	G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.	Device	Class II	1	Terminated
25 Aug 2017	AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.	Device	Class II	2	Terminated
22 Aug 2017	Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.	Device	Class II	1	Terminated
7 Aug 2017	Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM	Device	Class II	65	Terminated
7 Aug 2017	Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.	Device	Class II	4	Terminated
1 Aug 2017	Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal…	Device	Class II	2	Terminated
5 Jul 2017	Persona Partial Knee System, Size 8, Finishing Guide	Device	Class II	1	Terminated
30 Jun 2017	DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty	Device	Class II	2	Terminated
29 Jun 2017	PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended for uncemented use…	Device	Class II	1	Terminated
16 Jun 2017	ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom of the tray for…	Device	Class II	1	Terminated
12 Jun 2017	DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE	Device	Class II	1	Terminated
5 Jun 2017	M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide…	Device	Class II	5	Terminated
5 Jun 2017	Lateral Troch Plate Full Crimp - 254mm, model # 350837	Device	Class II	10	Terminated
22 May 2017	Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile	Device	Class II	60	Terminated
8 May 2017	Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.	Device	Class II	1	Terminated
1 May 2017	ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.	Device	Class II	2	Terminated
28 Apr 2017	VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H	Device	Class II	8	Terminated
28 Apr 2017	NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.	Device	Class II	1	Terminated
26 Apr 2017	Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into…	Device	Class II	1	Terminated
25 Apr 2017	Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.	Device	Class II	1	Terminated
17 Apr 2017	AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor…	Device	Class II	1	Terminated
13 Apr 2017	Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin	Device	Class II	1	Terminated
12 Apr 2017	Bone Dowell Harvest Tubes	Device	Class II	1	Terminated
22 Mar 2017	Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled…	Device	Class II	1	Terminated
28 Feb 2017	Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants	Device	Class II	35	Terminated
27 Feb 2017	MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurological procedure…	Device	Class II	2	Terminated
17 Feb 2017	various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and,…	Device	Class II	6	Terminated
14 Feb 2017	Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.	Device	Class II	1	Terminated
10 Jan 2017	1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw	Device	Class II	1	Terminated
4 Jan 2017	Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Item…	Device	Class II	1	Terminated
20 Dec 2016	Comprehensive Reverse Shoulder System Humeral Tray Model 115340	Device	Class I	1	Terminated
19 Dec 2016	RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223	Device	Class II	2	Terminated
16 Dec 2016	Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies	Device	Class II	1	Terminated
15 Dec 2016	Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265	Device	Class II	1	Terminated
6 Dec 2016	Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier.…	Device	Class II	1	Terminated
11 Oct 2016	ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in…	Device	Class II	1	Terminated
28 Sep 2016	Zimmer Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece	Device	Class II	1	Terminated
16 Aug 2016	Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the outer cavity. The patient record label…	Device	Class II	1	Terminated
9 Aug 2016	Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: ” Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. “ Correction of varus, valgus, or posttraumatic deformity. “ Correction or revision of unsuccessful…	Device	Class II	1	Terminated
9 Aug 2016	Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, and the fixation of…	Device	Class II	2	Terminated
8 Aug 2016	Vanguard 360 Revision Knee System Knee prostheses	Device	Class II	1	Terminated
2 Aug 2016	Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant into the humeral canal after the fracture…	Device	Class II	1	Terminated
29 Jul 2016	ROSA BRAIN 3.0.0	Device	Class II	1	Terminated
20 Jul 2016	ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical…	Device	Class II	1	Terminated
27 May 2016	ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.	Device	Class II	1	Terminated
11 May 2016	Persona Trabecular Metal„ Tibia; Persona„ Trabecular Metal„ Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.	Device	Class II	1	Terminated
8 Apr 2016	ROSA Surgical Device 2.5.8	Device	Class II	1	Terminated
11 Feb 2016	M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093	Device	Class II	1	Terminated
20 Jan 2016	Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used…	Device	Class II	1	Terminated
11 Jan 2016	LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders,…	Device	Class II	21	Terminated
9 Dec 2015	Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.	Device	Class II	1	Terminated
9 Dec 2015	Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.	Device	Class II	1	Terminated
17 Nov 2015	Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952	Device	Class II	1	Terminated
29 Oct 2015	Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan…	Device	Class II	1	Terminated
6 Nov 2014	ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.	Device	Class II	1	Terminated
5 Sep 2014	ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging…	Device	Class II	1	Terminated
4 Jun 2014	ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is…	Device	Class II	1	Terminated
14 Feb 2014	ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide	Device	Class II	1	Terminated
18 Dec 2013	ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging…	Device	Class II	1	Terminated
10 Feb 2013	ROSA Surgical Device 2.5.8	Device	Class II	1	Terminated
5 Feb 2013	ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging…	Device	Class II	1	Terminated
19 Apr 2012	ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging…	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Zimmer Biomet, Inc.: events for each product type
Type		Events
Device		144

Zimmer Biomet, Inc.: events in each class
Class		Events
Class II		142
Class I		2

Share of the events of the firm in Class I: 1%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Zimmer Biomet, Inc., by the year that the recall started. The largest year is 2017, with 48 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Zimmer Biomet, Inc.: FDA recalls. https://recallregister.com/firm/zimmer-biomet-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: IN

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Zimmer Biomet, Inc. have?: Class II: 142 events. Class I: 2 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Zimmer Biomet, Inc.?: FDA event 86869, which the firm started on 20 Nov 2020. The first product in the record is: Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.
How many FDA recalls of Zimmer Biomet, Inc. have the status Ongoing?: No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.