CLASS II Device recall · Reported 15 Aug 2018 · FDA Enforcement Report

rHead Recon Stem Implant non-coated recalled by Howmedica Osteonics

Howmedica Osteonics is recalling rHead Recon Stem Implant non-coated, Size Orthopedic implant for replacement of the, distributed nationwide in the US. The recall was initiated on 24 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRCN-S360

Quantity recalled141

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2719-2018
FDA event ID: 79315
Recalling firm: Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Terminated
Recall initiated: 24 Oct 2017
FDA classified: 8 Aug 2018
Reported: 15 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

24 Oct 2017	Recall initiated by company
8 Aug 2018	Classified by FDA	+288 days
15 Aug 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Distribution US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

RCN-S360

Where was it sold?

Distribution US Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

69 other products · FDA event 79315

This product is part of a recall event; the main page for the event is radial stem implant #3 (Sterile packed) recalled by Howmedica Osteonics.

Reported	Class	Recall	Company	Reason	Where
15 Aug 2018	CLASS II	radial stem implant #3 (Sterile packed) recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	Radio Capitellum Small, Left recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Lateral Assembly, Radial Head Impl Assembly recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Recon Stem Implant non-coated recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	#4 Bipolar radial head Implant (Sterile packed) recalled	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	Lat Assembly, Rad Stem Implant,Collar,Size Orthopedic recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Lateral Assembly, Radial Head Impl Assembly recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Recon Stem Implant Plasma Coated recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	radial stem implant #1 (Sterile packed) recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	Lateral Assembly, Radial Head Impl Assembly recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Lateral Assembly, Radial Head Implant recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	#2 Bipolar stem implant (Sterile packed) recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	Radio Capitellum Large, Right recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Recon Stem Implant Collar,Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	#1 Bipolar stem implant (Sterile packed) recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	#3 Bipolar stem implant (Sterile packed) recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	Radial Head Assy Size #4, Rad recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Standard Extended Stem Collar recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Radio Capitellum Broach Large, Right recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Radio Capitellum, Recon Head, Size #3 recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	radial stem implant #2 (Sterile packed) recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	#4 Bipolar stem implant (Sterile packed) recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	rHead Recon Stem Implant Plasma Coated recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Stem Implant Collar, Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Recon Stem Implant Collar, Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Recon Extended Stem Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead, Radial Implant Collar, Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Radio Capitellum, Recon Head, Size #4 recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Recon Stem Implant Plasma Coated recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	#3 Bipolar radial head Implant (Sterile packed) recalled	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	rHead Stem Implant Collar, Size 4.Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Lateral Assembly, Radial Head Implant recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Standard Extended Stem Collar recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Recon Extended Stem Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Recon Stem Implant non-coated recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	#2 Bipolar radial head Implant (Sterile packed) recalled	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	Radio Capitellum Large, Left Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Radio Capitellum, Recon Head, Size #2 recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Stem Implant Plasma Coated recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	radial head implant #4 (Sterile packed) recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	rHead Recon Stem Implant non-coated recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Lateral Assembly, Radial Head Implant recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Stem Implant Collar, Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Lateral Assembly, Radial Stem Implant recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Stem Implant Plasma Coated recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Standard Extended Stem Collar recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	radial head implant #3 (Sterile packed) recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	radial stem implant #4 (Sterile packed) recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	Lat Assembly, Rad Stem Implant,Collar, Size1 recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Radial Head Assy Size #3, Rad recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Radial Head Assy Size #2, Rad recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Stem Implant Plasma Coated recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	radial head implant #2 (Sterile packed) recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	Lat Assembly, Rad Stem Implant,Collar,Size Orthopedic recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Lateral Assembly, Radial Stem Implant recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Lateral Assembly, Radial Stem Implant recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Lateral Assembly, Radial Implant recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Stem Implant Collar, Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	radial stem implant #2 (Sterile packed) recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	Nationwide
15 Aug 2018	CLASS II	rHead Recon Extended Stem Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Recon Stem Implant Collar, Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Stem Implant Plasma Coated recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Lat Assembly, Rad Stem Implant,Collar,Size Orthopedic recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead, Radial Implant Collar, Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Standard Extended Stem Collar recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	Radio Capitellum Small, Right recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Recon Stem Implant Collar, Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead, Radial Implant Collar, Size Orthopedic implant recalled	Howmedica Osteonics	Device Malfunction	Nationwide
15 Aug 2018	CLASS II	rHead Recon Stem Implant Plasma Coated recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide

More recalls from Howmedica Osteonics

All 232

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Tri Ts Baseplate Size recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	Nationwide
24 Jun 2026Device	CLASS II	Tri Ts Baseplate Size recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	Nationwide
25 Mar 2026Device	CLASS II	MICS3 Angled Sagittal Saw Attachment recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
31 Dec 2025Device	CLASS II	The Stryker CranialMask Tracker is a single-use device recalled	Howmedica Osteonics	Device Malfunction	Nationwide
8 Oct 2025Device	CLASS II	Exeter V40 Stem No recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Nitrosamine Impurity	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide