Recall Z-0915-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Inc.
NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.
| Date | Mar 2, 2010 (initiated Jan 27, 2010) |
| Status | Terminated |
| Reason | The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified. |
| Root cause | Labeling mix-ups |
| Action | The firm sent an immediate notification by e-mail to all first consignees on 1/12/2010. They sent a formal recall notification on 1/27/2010. Customers should contact their Zimmer Sales representative with additional questions. |
| Quantity | 14 units |
| Distribution | US and Korea. |
| 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 |