Device recall: 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787…

Class II FDA enforcement event 86896. Recall start date: 25 Nov 2020. Status in the FDA record: Terminated. Termination date: 8 May 2024.

Reason for recall, in the words of FDA

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Biomet, Inc. started this device recall on 25 Nov 2020. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 86896 has 16 product records. The first FDA enforcement report date is 23 Dec 2020. The record gives the status Terminated, with the termination date 8 May 2024.

FDA enforcement report The 16 product records

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.

Distribution

In the words of FDA.

Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN

Recalling firm

Biomet, Inc., Warsaw, IN.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

16 product records in the event.

FDA event 86896: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0616-2021	3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.	7,428 units	Class II	Terminated	23 Dec 2020
Z-0617-2021	4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.	N/A	Class II	Terminated	23 Dec 2020
Z-0618-2021	6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage: Fracture fixationof small bones, small bone…	7428	Class II	Terminated	23 Dec 2020
Z-0619-2021	Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or…	7428	Class II	Terminated	23 Dec 2020
Z-0620-2021	Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.	7428	Class II	Terminated	23 Dec 2020
Z-0621-2021	Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the…	7428	Class II	Terminated	23 Dec 2020
Z-0622-2021	M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.	7428	Class II	Terminated	23 Dec 2020
Z-0623-2021	OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.	7428	Class II	Terminated	23 Dec 2020
Z-0624-2021	Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.	7428	Class II	Terminated	23 Dec 2020
Z-0625-2021	PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long bones.	7428	Class II	Terminated	23 Dec 2020
Z-0626-2021	RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.	7428	Class II	Terminated	23 Dec 2020
Z-0627-2021	RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component);…	7428	Class II	Terminated	23 Dec 2020
Z-0628-2021	RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,…	7428	Class II	Terminated	23 Dec 2020
Z-0629-2021	Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone	7428	Class II	Terminated	23 Dec 2020
Z-0630-2021	Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.	7428	Class II	Terminated	23 Dec 2020
Z-0631-2021	RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.	7428	Class II	Terminated	23 Dec 2020

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 16Median of the firm: 1
Events of the firm on the register: 84

Other events of the firm

Other FDA enforcement events of Biomet, Inc.
Initiated	Product (first record)	Type	Class	Records
1 Jul 2026	Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade A	Device	Class II	5
23 Sep 2025	BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Rep	Device	Class II	1
9 Sep 2025	Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080	Device	Class II	1
21 Oct 2024	JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357	Device	Class II	1
17 May 2024	RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206	Device	Class II	1
13 Mar 2024	Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foi	Device	Class II	1
2 Nov 2023	Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01	Device	Class II	2
9 Oct 2023	Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ	Device	Class II	19
6 Feb 2023	G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462	Device	Class II	1
29 Dec 2022	(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number:	Device	Class II	2

Biomet, Inc.: all 84 events

Official channels

FDA enforcement report Z-0616-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 86896. https://recallregister.com/fda/ii/86896/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
What quantity of product is in FDA event 86896?: The event has 16 product records. The first record gives this quantity: 7,428 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.