Howmedica Osteonics Corp.: FDA recalls

FDA enforcement reports name Howmedica Osteonics Corp. as the recalling firm in 48 events. The events have 244 product records. The recalls started from 2016 to 2026. All the events are device recalls.

See the 48 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

48 events, newest first.

FDA enforcement events of Howmedica Osteonics Corp.
Initiated	Product (first record)	Type	Class	Records	Status
30 Jul 2026	AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)	Device	Class II	12	Ongoing
19 May 2026	TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.	Device	Class II	2	Ongoing
2 Feb 2026	MICS3 Angled Sagittal Saw Attachment; Part Number: 210490	Device	Class II	1	Ongoing
12 Nov 2025	The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three…	Device	Class II	1	Ongoing
28 Aug 2025	1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;	Device	Class II	1	Ongoing
4 Sep 2024	Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200	Device	Class II	1	Ongoing
7 Aug 2024	MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063	Device	Class II	1	Ongoing
5 Aug 2024	Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;	Device	Class II	1	Ongoing
19 Jun 2024	UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043	Device	Class II	3	Ongoing
23 May 2024	HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900	Device	Class II	2	Ongoing
27 Feb 2024	TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B	Device	Class II	12	Ongoing
6 Feb 2024	X3 TRIATHLON CS INSERT NO 3 10 MM	Device	Class II	8	Ongoing
22 Dec 2023	HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty	Device	Class II	2	Ongoing
1 Dec 2023	SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026	Device	Class II	58	Ongoing
3 May 2023	Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026	Device	Class II	1	Ongoing
13 Apr 2023	TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E	Device	Class II	2	Ongoing
10 Mar 2023	stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure	Device	Class II	2	Ongoing
7 Nov 2022	Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001	Device	Class III	2	Ongoing
21 Oct 2022	Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010	Device	Class II	1	Ongoing
24 Aug 2022	Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.	Device	Class II	1	Ongoing
30 Mar 2022	Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500	Device	Class II	1	Ongoing
14 Jan 2022	Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032	Device	Class II	2	Ongoing
30 Dec 2021	Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044	Device	Class II	2	Terminated
21 Dec 2021	32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032	Device	Class II	2	Ongoing
24 Nov 2021	Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109	Device	Class II	1	Ongoing
15 Oct 2021	28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028	Device	Class II	2	Ongoing
1 Jul 2021	Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700	Device	Class II	1	Terminated
5 Mar 2021	Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set I-K3834CG1L Specialty Triathlon TS Trial Cutting…	Device	Class II	1	Terminated
10 Feb 2021	Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.	Device	Class II	1	Terminated
16 Apr 2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)	Device	Class II	16	Terminated
1 Apr 2020	Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010	Device	Class II	1	Terminated
7 Nov 2019	Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254	Device	Class II	1	Terminated
3 Oct 2019	Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025	Device	Class II	1	Terminated
19 Aug 2019	TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See…	Device	Class II	4	Terminated
18 Jun 2019	Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100	Device	Class II	1	Terminated
28 Nov 2018	Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.	Device	Class II	1	Terminated
26 Nov 2018	Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF procedure.	Device	Class II	1	Terminated
15 Nov 2018	HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE	Device	Class II	2	Terminated
12 Sep 2018	Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then rotate for desired…	Device	Class II	1	Terminated
10 Sep 2018	Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or wrist…	Device	Class II	1	Terminated
22 May 2018	LFIT Anatomic CoCr Femoral Heads, 6260-9-036	Device	Class II	8	Terminated
30 Jan 2018	Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.	Device	Class II	1	Terminated
12 Jan 2018	Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function	Device	Class II	1	Terminated
21 Dec 2017	Custom Made Implant System with Minimum Invasive Grower (MIG) component	Device	Class II	1	Terminated
24 Oct 2017	Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	Device	Class II	70	Terminated
8 Sep 2017	AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in the anterior portion of the intervertebral…	Device	Class II	1	Terminated
21 Jul 2017	Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737	Device	Class II	2	Terminated
26 Jul 2016	AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with…	Device	Class II	3	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

Howmedica Osteonics Corp.: events for each product type
Type		Events
Device		48

Howmedica Osteonics Corp.: events in each class
Class		Events
Class II		47
Class III		1

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 25

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 Howmedica Osteonics Corp., by the year that the recall started. The largest year is 2018, with 8 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. Howmedica Osteonics Corp.: FDA recalls. https://recallregister.com/firm/howmedica-osteonics-corp/. 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: NJ

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 Howmedica Osteonics Corp. have?: Class II: 47 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Howmedica Osteonics Corp.?: FDA event 99558, which the firm started on 30 Jul 2026. The first product in the record is: AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
How many FDA recalls of Howmedica Osteonics Corp. have the status Ongoing?: 25 events have 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.