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.
- Recall Initiated
- June 3, 2016
- Terminated
- August 1, 2018
- Recall Number
- Z-2281-2016
- Quantity
- 1,864 units
- Firm Location
- Mahwah, NJ
Reason for Recall
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
Distribution
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.
Lot / Code Info
Catalog Nos. 2199-2022, 2199-2028 and 2199-2032 All lots manufactured from May 30, 2012
Root Cause
Process design
Action Taken
Stryker notified its branches/agencies of this recall by e-mail on May 26, 2016. They were asked to quarantine the affected devices. Stryker sent a recall letter and business reply form dated June 3, 2016 to their affected customers via UPS. Stericycle will be handling the returns.