NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.
FDA device recall Z-0915-2010 · posted 2010-03-02 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 14 units
- Distribution
- US and Korea.
- Date initiated
- 2010-01-27
- Date posted
- 2010-03-02
- Date terminated
- 2010-10-17
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS (K060370) | Zimmer, Inc. | 2006-04-28 |