Reported Mar 2, 2016 · Terminated
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments…
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?
- Stryker, Gamma K-Wire 3.2x450 mm
- UNS-Thread Product UsageIntended for the temporary stabilization of bone segments or fragments
- Lot codes and dates
- Catalog number 1210-6451S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
- Amount recalled
- 147,838 units in total
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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