Reported Aug 3, 2016 · Terminated
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog…
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 Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
- Lot codes and dates
- Catalog Nos. 2199-2022, 2199-2028 and 2199-2032 All lots manufactured from May 30, 2012
- Amount recalled
- 1,864 units
Where it was sold
Why it was recalled
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
This product could cause temporary or reversible health problems — stop using it.
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