Device recall: Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the…

Class II FDA enforcement event 79315. Recall start date: 24 Oct 2017. Status in the FDA record: Terminated. Termination date: 18 May 2023.

Reason for recall, in the words of FDA

Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

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

Howmedica Osteonics Corp. started this device recall on 24 Oct 2017. The firm address in the FDA record is in Mahwah, NJ. FDA put the recall in Class II. FDA event 79315 has 70 product records. The first FDA enforcement report date is 15 Aug 2018. The record gives the status Terminated, with the termination date 18 May 2023.

FDA enforcement report The 70 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.

Distribution US Nationwide.

Recalling firm

Howmedica Osteonics Corp., Mahwah, NJ.

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

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

Products

70 product records in the event.

FDA event 79315: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2663-2018	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.	211	Class II	Terminated	15 Aug 2018
Z-2664-2018	Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	396	Class II	Terminated	15 Aug 2018
Z-2665-2018	Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	492	Class II	Terminated	15 Aug 2018
Z-2666-2018	Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	280	Class II	Terminated	15 Aug 2018
Z-2667-2018	Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	170	Class II	Terminated	15 Aug 2018
Z-2668-2018	Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	190	Class II	Terminated	15 Aug 2018
Z-2669-2018	Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	230	Class II	Terminated	15 Aug 2018
Z-2670-2018	Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	175	Class II	Terminated	15 Aug 2018
Z-2671-2018	Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	283	Class II	Terminated	15 Aug 2018
Z-2672-2018	Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	690	Class II	Terminated	15 Aug 2018
Z-2673-2018	Lateral Assembly, Radial Head Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	285	Class II	Terminated	15 Aug 2018
Z-2674-2018	Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	150	Class II	Terminated	15 Aug 2018
Z-2675-2018	Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	191	Class II	Terminated	15 Aug 2018
Z-2676-2018	Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	81	Class II	Terminated	15 Aug 2018
Z-2677-2018	rHead Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	270	Class II	Terminated	15 Aug 2018
Z-2678-2018	rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	285	Class II	Terminated	15 Aug 2018
Z-2679-2018	rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	320	Class II	Terminated	15 Aug 2018
Z-2680-2018	rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	301	Class II	Terminated	15 Aug 2018
Z-2681-2018	rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	245	Class II	Terminated	15 Aug 2018
Z-2682-2018	rHead Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	268	Class II	Terminated	15 Aug 2018
Z-2683-2018	rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	305	Class II	Terminated	15 Aug 2018
Z-2684-2018	rHead Stem Implant 6mm Collar, Size 4.Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	256	Class II	Terminated	15 Aug 2018
Z-2685-2018	rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	314	Class II	Terminated	15 Aug 2018
Z-2686-2018	rHead Recon Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	303	Class II	Terminated	15 Aug 2018
Z-2687-2018	rHead Recon Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	396	Class II	Terminated	15 Aug 2018
Z-2688-2018	rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	310	Class II	Terminated	15 Aug 2018
Z-2689-2018	rHead Recon Stem Implant 6mm Collar,Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	265	Class II	Terminated	15 Aug 2018
Z-2690-2018	rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	269	Class II	Terminated	15 Aug 2018
Z-2691-2018	rHead Recon Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	298	Class II	Terminated	15 Aug 2018
Z-2692-2018	rHead Recon Stem Implant 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	216	Class II	Terminated	15 Aug 2018
Z-2693-2018	Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	170	Class II	Terminated	15 Aug 2018
Z-2694-2018	Radio Capitellum Small, Left. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	214	Class II	Terminated	15 Aug 2018
Z-2695-2018	Radio Capitellum Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	158	Class II	Terminated	15 Aug 2018
Z-2696-2018	Radio Capitellum Small, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	121	Class II	Terminated	15 Aug 2018
Z-2697-2018	Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	128	Class II	Terminated	15 Aug 2018
Z-2698-2018	Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	166	Class II	Terminated	15 Aug 2018
Z-2699-2018	Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	107	Class II	Terminated	15 Aug 2018
Z-2700-2018	Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	163	Class II	Terminated	15 Aug 2018
Z-2701-2018	Radio Capitellum, Recon Head, Size #3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	225	Class II	Terminated	15 Aug 2018
Z-2702-2018	Radio Capitellum, Recon Head, Size #4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	124	Class II	Terminated	15 Aug 2018
Z-2703-2018	rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	33	Class II	Terminated	15 Aug 2018
Z-2704-2018	rHead Standard Extended Stem, 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	66	Class II	Terminated	15 Aug 2018
Z-2705-2018	rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	45	Class II	Terminated	15 Aug 2018
Z-2706-2018	rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	36	Class II	Terminated	15 Aug 2018
Z-2707-2018	rHead Recon Extended Stem Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	19	Class II	Terminated	15 Aug 2018
Z-2708-2018	rHead Recon Extended Stem Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	19	Class II	Terminated	15 Aug 2018
Z-2709-2018	rHead Recon Extended Stem Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	19	Class II	Terminated	15 Aug 2018
Z-2710-2018	Radio Capitellum Broach Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	10	Class II	Terminated	15 Aug 2018
Z-2711-2018	#2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	605	Class II	Terminated	15 Aug 2018
Z-2712-2018	#3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	999	Class II	Terminated	15 Aug 2018
Z-2713-2018	#4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	546	Class II	Terminated	15 Aug 2018
Z-2714-2018	#1 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	169	Class II	Terminated	15 Aug 2018
Z-2715-2018	rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	90	Class II	Terminated	15 Aug 2018
Z-2716-2018	#2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	543	Class II	Terminated	15 Aug 2018
Z-2717-2018	rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	133	Class II	Terminated	15 Aug 2018
Z-2718-2018	#3 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	673	Class II	Terminated	15 Aug 2018
Z-2719-2018	rHead Recon Stem Implant non-coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	141	Class II	Terminated	15 Aug 2018
Z-2720-2018	#4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	387	Class II	Terminated	15 Aug 2018
Z-2721-2018	rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	118	Class II	Terminated	15 Aug 2018
Z-2722-2018	radial head implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.	607	Class II	Terminated	15 Aug 2018

The table shows 60 of 70 product records. The FDA enforcement report lists all the records.

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 2017: 1,091
Share of these events in Class II: 93%
Product records in this event: 70Median of the firm: 1
Events of the firm on the register: 48

Other events of the firm

Other FDA enforcement events of Howmedica Osteonics Corp.
Initiated	Product (first record)	Type	Class	Records
30 Jul 2026	AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE	Device	Class II	12
19 May 2026	TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.	Device	Class II	2
2 Feb 2026	MICS3 Angled Sagittal Saw Attachment; Part Number: 210490	Device	Class II	1
12 Nov 2025	The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infr	Device	Class II	1
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: 05	Device	Class II	1
4 Sep 2024	Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications dur	Device	Class II	1
7 Aug 2024	MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063	Device	Class II	1
5 Aug 2024	Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100	Device	Class II	1
19 Jun 2024	UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 69	Device	Class II	3
23 May 2024	HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900	Device	Class II	2

Howmedica Osteonics Corp.: all 48 events

Official channels

FDA enforcement report Z-2663-2018The 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.

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Cite this page

Recall Register. FDA enforcement event 79315. https://recallregister.com/fda/ii/79315/. 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: Distribution US Nationwide.
What quantity of product is in FDA event 79315?: The event has 70 product records. The first record gives this quantity: 211
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2017 have the same class?: 93% of the 1,091 device events that started in 2017 are in Class II.