Recall Z-2552-2014 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer, Inc.
Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMDX130MM CEMENTED STEM EXT 13MM X 145MM IMPACTOR SLEEVE* NGK STEM EXT 12X245MM (200MM) NGK STEM EXT 13X245MM (200MM) NGK STEM EXT 1
| Date | Aug 26, 2014 (initiated Jul 22, 2014) |
| Status | Terminated |
| Reason | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost. |
| Root cause | Package design/selection |
| Action | Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice. |
| Quantity | 972,125 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933785 | NEXT GENERATION KNEE SYSTEM Zimmer, Inc., Jan 30, 1995 |