Z-2281-2016 Class II Terminated
FDA device recall Z-2281-2016 was initiated by Stryker Howmedica Osteonics Corp. on June 3, 2016 and is designated Class II. Reason for recall: Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method. The recall status is terminated (terminated August 1, 2018). Affected quantity: 1,864 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2016
- Initiation Date
- June 3, 2016
- Termination Date
- August 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,864 units
Product Description
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.
Reason for Recall
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
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.
Code Information
Catalog Nos. 2199-2022, 2199-2028 and 2199-2032 All lots manufactured from May 30, 2012