Recall Z-0349-2012 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial Baseplate stem. P/N 801-01-013
| Date | Dec 2, 2011 (initiated Oct 26, 2011) |
| Status | Terminated |
| Reason | The strike plate may dislodge from the broach stem handle during impaction of the device. |
| Root cause | Nonconforming Material/Component |
| Action | DJO Global sent an URGENT FIELD SAFETY NOTICE letter dated October 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the information to all those who need to be aware within their organization or to any organization where the affected devices have been transferred. Customers should contact Customer Service to place a replacement order and receive an RMA number and return all affected devices using the RMA number. For any questions call (512) 834-6255. |
| Quantity | 30 units |
| Distribution | Worldwide Distribution - USA including AR, AZ, CA, LA, MD, NY, TX, UT and Puerto Rico and the countries of United Kingdom and Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970031 | FOUNDATION KNEE SYSTEM TIBIAL COMPONENT Encore Orthopedics, Inc., Apr 2, 1997 |