Reported Aug 26, 2015 · Terminated
Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or…
Stryker Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- 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.
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 410-0000(Radio Capitellum Large, Left) - Lot #'s 18832, 22193201, 22193202, 22193203, 22258301,22957101, 23853901, 19069-S2, 19077-S2 and 19155S2 410-0001(Radio Capitellum Small, Left) - Lot #'s18833, 18834, 22193302, 22193303, 22766801, 2295601 and 23853101 410-0002(Radio Capitellum Large, Right) - Lot #'s18835, 18836, 22193401, 22193402, 22193403, 22766901, 22956301, 23853201 and 19074-S2 410-0003(Radio Capitellum Small, Right) - Lot #'s 18565, 22193501, 22193502, 22193503, 22767001, 22956401 and 23853301 - Amount recalled
- 16992 total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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