Recall Z-2377-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Tria
| Date | Jun 23, 2016 |
| Status | Terminated |
| Reason | Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument. |
| Root cause | Device Design |
| Action | Stryker sent an Urgent Product Recall letter dated June 24, 2016 to Branches/Agencies by e-mail and Business Reply Forms was sent to Branches/Agents/Hospital Risk Management via UPS (with return receipt) on June 24, 2016. The letter identified the affected product, problem and actions to be taken. For questions call (201) 831-6693. |
| Quantity | 12,469 units |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143393 | Triathlon Tritanium Cone Augments Stryker Orthopaedics, Jan 13, 2015 |