Recall Z-1061-2013 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France The Baseplate Impactor Extractor is intended to securely attach to the tibial baseplate or baseplate trial for im
| Date | Apr 5, 2013 (initiated Feb 23, 2013) |
| Status | Terminated |
| Reason | Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly. |
| Root cause | Nonconforming Material/Component |
| Action | Stryker sent Notification Letters/Product Accountablility Forms dated March 1, 2013 via FedEx to their Branches/Agencies on March 1, 2013.. Notification Letters/Product Recall Acknowledgement Forms dated March 4, 2013, were sent via FedEx to Hospital Risk Management on March 4, 2013. The Notification letters identified the product, the problem, and instructed customers on how to identify affected product; informs customers of the issues and potential hazards with the affected product and instructs them to contact their representative to arrange for return/replacement of any affected product. |
| Quantity | 871 units |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Canada, Japan, Australia, China, New Zealand, France, Italy, Netherlands, Poland, Spain, Sweden, Switzerland and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.