Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, ste
FDA device recall Z-1477-2009 · posted 2009-06-26 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The tyvek lid, which is intended to assure sterility until the device is transported to the operating room, may be missing from the inner tray.
- Action taken
- Zimmer, Inc. issued an "Urgent: Device Recall" letter dated April 29, 2009 informing all consignees of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 14
- Distribution
- Worldwide Distribution -- US including states of FL, MN, MS, NY, OH, TN, TX and WI and Switzerland.
- Date initiated
- 2009-04-29
- Date posted
- 2009-06-26
- Date terminated
- 2009-10-21
- 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 |
|---|---|---|
| GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM (K070214) | Zimmer, Inc. | 2007-03-16 |