CLASS II Device recall · Reported 26 Aug 2015 · FDA Enforcement Report

Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse recalled

Stryker Howmedica Osteonics is recalling Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse. The recall was initiated on 24 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 410-0000 (Radio Capitellum Large, Left) - Lot #'s 18832, 22193201, 22193202, 22193203, 22258301,22957101, 23853901, 19069-S2, 19077-S2 and 19155S2; Part Number: 410-0001 (Radio Capitellum Small, Left) - Lot #'s18833, 18834, 22193302, 22193303, 22766801, 2295601 and 23853101; Part Number: 410-0002 (Radio Capitellum Large, Right) - Lot #'s18835, 18836, 22193401, 22193402, 22193403, 22766901, 22956301, 23853201 and 19074-S2; Part Number: 410-0003 (Radio Capitellum Small, Right) - Lot #'s 18565, 22193501, 22193502, 22193503, 22767001, 22956401 and 23853301

Quantity recalled16992 total

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-2428-2015
FDA event ID: 71676
Recalling firm: Stryker Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Terminated
Recall initiated: 24 Jun 2015
FDA classified: 20 Aug 2015
Reported: 26 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

24 Jun 2015	Recall initiated by company
20 Aug 2015	Classified by FDA	+57 days
26 Aug 2015	Published in enforcement report	+6 days

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

Reason for recall

Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.

Where it was distributed

Worldwide Distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

Part Number: 410-0000 (Radio Capitellum Large, Left) - Lot #'s 18832, 22193201, 22193202, 22193203, 22258301,22957101, 23853901, 19069-S2, 19077-S2 and 19155S2; Part Number: 410-0001 (Radio Capitellum Small, Left) - Lot #'s18833, 18834, 22193302, 22193303, 22766801, 2295601 and 23853101; Part Number: 410-0002 (Radio Capitellum Large, Right) - Lot #'s18835, 18836, 22193401, 22193402, 22193403, 22766901, 22956301, 23853201 and 19074-S2; Part Number: 410-0003 (Radio Capitellum Small, Right) - Lot #'s 18565, 22193501, 22193502, 22193503, 22767001, 22956401 and 23853301

Where was it sold?

Worldwide Distribution.

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 26 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

4 other products · FDA event 71676

This product is part of a recall event; the main page for the event is rHead Lateral Stem, Size 1, Do Not Reuse, Sterile recalled.

Reported	Class	Recall	Company	Reason	Where
26 Aug 2015	CLASS II	rHead Lateral Stem, Size 1, Do Not Reuse, Sterile recalled	Stryker Howmedica Osteonics	Sterility	NJ
26 Aug 2015	CLASS II	uHead, Ulnar Implant, Standard Stem, Size 1, Sterile recalled	Stryker Howmedica Osteonics	Sterility	NJ
26 Aug 2015	CLASS II	Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse recalled	Stryker Howmedica Osteonics	Sterility	NJ
26 Aug 2015	CLASS II	Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse recalled	Stryker Howmedica Osteonics	Sterility	NJ

More recalls from Stryker Howmedica Osteonics

All 86

Reported	Class	Recall	Company	Reason	Where
31 May 2017Device	CLASS II	Hoffmann LRF Safety Clip (Bone Transport Strut) recalled	Stryker Howmedica Osteonics	Other	Nationwide
18 Jan 2017Device	CLASS II	Reunion TSA Peg Alignment Sound recalled by Stryker Howmedica Osteonics	Stryker Howmedica Osteonics	Other	Nationwide
28 Dec 2016Device	CLASS II	GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R recalled	Stryker Howmedica Osteonics	Sterility	Nationwide
16 Nov 2016Device	CLASS II	LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile recalled	Stryker Howmedica Osteonics	Device Malfunction	Nationwide
19 Oct 2016Device	CLASS II	Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor recalled	Stryker Howmedica Osteonics	Other	NJ

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