Reported Apr 4, 2018 · Terminated
180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for…
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?
- 180-Gram Cement Cartridge with Breakaway Femoral Nozzle
- Product Number0206-530-000
- UDI(01)4546540857880 for orthopedic use
- Lot codes and dates
- Lot Numbers
1727701217283012
- UDI(01)4546540857880
- Lot Numbers
- Amount recalled
- 708
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.
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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