Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V al
FDA device recall Z-0767-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants.
- Action taken
- Consignees were notified via e-mail on 3/16/04. Consignees were asked to secure their inventory from use and to notify all customers if they had further distributed the product. Product shipped to Japan and Singapore was contained prior to shipment to hospitals.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDC
- Distribution
- United States, Australia, Canada, Finland, France, Germany, Israel, Italy, Japan, Korea, Singapore, Spain, and the United Kingdom.
- Date initiated
- 2004-03-16
- Date posted
- 2004-07-20
- Date terminated
- 2004-06-26
- 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 TOTAL ELBOW. MODEL 32-8105 SERIES (K001989) | Zimmer, Inc. | 2000-07-25 |