Zimmer Coonrad/Morrey total elbow cement restrictor with nozzle, 1 - 16 mm, 1 - 25 mm, sterile, Zimmer, Dover, Ohio; Cat
FDA device recall Z-1700-2009 · posted 2009-07-23 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
- Action taken
- Zimmer Orthopedic Surgical Products issued an "Urgent: Medical Device Recall" notice dated June 8, 2009 informing users of the affected devices and actions to be taken including the return of product and acknowledgement of receipt of notice by returning the Recall Certification Form by fax to 1-330-364-0974.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 110
- Distribution
- Worldwide Distribution -- United States, Canada and Japan.
- Date initiated
- 2009-06-08
- Date posted
- 2009-07-23
- Date terminated
- 2009-12-15
- 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 |
|---|---|---|
| COONRAD/MORREY ELBOW CEMENT RESTRICTOR (K040389) | Zimmer, Inc. | 2004-05-17 |