Device 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.
Z-2281-2016
Product summary
- Event
- Event 74500
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,864 units
- Official record key
device-enforcement:Z-2281-2016
Official wording
Reason: Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
Code information: Catalog Nos. 2199-2022, 2199-2028 and 2199-2032 All lots manufactured from May 30, 2012
Distribution pattern: 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.
Derived failure modes
-
Unknown
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.