Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L; Catalog No.: 01.00211.146, Lot 2376766. Zimmer, Warsa
FDA device recall Z-0276-2008 · posted 2007-11-29 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Mislabeled as to size; 54mm package contains 46 mm device and vice versa.
- Action taken
- Zimmer GmbH notified Distributors via a Product Recall Notification letter, dated 9/26/07, instructing them to return the products and to subrecall.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KXA
- Quantity affected
- 5
- Distribution
- Nationwide
- Date initiated
- 2007-09-26
- Date posted
- 2007-11-29
- Date terminated
- 2008-06-04
- 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 |
|---|---|---|
| DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS (K070292) | Zimmer GmbH | 2007-04-26 |