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Stryker Howmedica Osteonics Corp. recalls Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog N
Recalled August 3, 2016 · FDA recall Z-2281-2016 · Stryker Howmedica Osteonics
Hazard
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method. · FDA Class II
Units
1,864 units
Sold at
Worldwide distribution. US nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OH, PA, TX, WA, WI, WV), Sweden, South Africa, Chile, Australia, New Zealand, Canada, United Kingdom, Switzerland, Colombia, and Poland.
Description
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
Product
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.
Manufacturer(s)
Stryker Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →