Recall Z-2281-2016 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Stryker Howmedica Osteonics Corp.
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.
| Date | Jun 3, 2016 |
| Status | Terminated |
| Reason | Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 1,864 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151264 | Restoration Anatomic Shell Stryker Orthopaedics, Aug 10, 2015 |