Recall Z-0761-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics, Mahwah, NJ 07430. The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.
| Date | Feb 1, 2010 (initiated Dec 10, 2009) |
| Status | Terminated |
| Reason | Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension. |
| Root cause | Nonconforming Material/Component |
| Action | An "Urgent Product Recall" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069. All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100. |
| Quantity | 9 |
| Distribution | Worldwide Distribution -- United States (DE, NC, OH. MI, TX, CA, MA, NJ, TN, KS, GA, FL, AL, IN, MN, MD, NE, AR, OK, CO, AZ, OR, and MA), Australia, United Kingdom and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070095 | TRIATHLON TS KNEE SYSTEM Howmedica Osteonics Corp., Jun 1, 2007 |