Recall Z-0501-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Inc.
Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52.
| Date | Dec 14, 2009 (initiated Nov 13, 2009) |
| Status | Terminated |
| Reason | The inner package may interfere with the outer seal, resulting in lack of assurance of sterility. |
| Root cause | Packaging process control |
| Action | Zimmer sent a recall letter, dated 11/12/09, to each initial consignee on 11/13/09. Zimmer field staff is to remove the product from affected hospitals, and to provide them with a copy of the recall letter. |
| Quantity | 22 |
| Distribution | Nationwide, Korea and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060370 | NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS Zimmer, Inc., Apr 28, 2006 |