Reported Apr 4, 2018 · Terminated
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
Stryker Instruments Div. of Stryker Corporation
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 Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
- Break-Away Femoral Nozzle
- Product Number0206-512-000
- UDI(01)4546540039415 for orthopedic use
- Lot codes and dates
- Lot Number17279012
- UDI(01)4546540039415
- Amount recalled
- 384
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
This product could cause temporary or reversible health problems — stop using it.
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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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