Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femor
FDA device recall Z-0501-2010 · posted 2009-12-14 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 22
- Distribution
- Nationwide, Korea and Switzerland.
- Date initiated
- 2009-11-13
- Date posted
- 2009-12-14
- Date terminated
- 2010-10-15
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS (K060370) | Zimmer, Inc. | 2006-04-28 |