Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fi
FDA device recall Z-1064-2010 · posted 2010-03-10 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The titanium portion of the implant may separate from the trabecular metal material.
- Action taken
- On December 1, 2009, an e-mail was sent to consignees for lot 60866613 to quarantine and return the product. On December 2, 2009 an e-mail was sent to U.S. distributors, and on December 3, 2009 and e-mail was sent to international distributors, instructing them to suspend usage and return all lots of size 8 trays. On December 9, 2009, a recall letter was sent to U.S. user accounts who received the products directly from Zimmer, U.S. distributors and Zimmer's U.S. sales force informing them of the recall. Direct questions about this recall to Zimmer, Inc. by calling 1-800-613-6131.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 846
- Distribution
- Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Saudi Arabia, Spain, Sweden, Switzerland and the United Kingdom.
- Date initiated
- 2009-11-16
- Date posted
- 2010-03-10
- Date terminated
- 2011-03-23
- 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 TRABECULAR METAL TIBIAL TRAY (K072160) | Zimmer, Inc. | 2007-09-05 |