Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented
FDA device recall Z-0032-2009 · posted 2008-10-03 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The component in the package is not the correct size.
- Action taken
- Consignees were notified by letter dated May 28, 2008 to locate and return the recalled lots. Contact Biomet Orthopedics at 1-800-348-9500, ext. 3983 for assistance.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JDC
- Quantity affected
- 6
- Distribution
- USA--California, Illinois, Indiana, Massachusetts, Ohio Puerto Rico, and Canada, OUS: Germany and Great Britain.
- Date initiated
- 2008-05-23
- Date posted
- 2008-10-03
- Date terminated
- 2009-09-22
- 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 |
|---|---|---|
| DISCOVERY ELBOW (K013042) | Biomet Orthopedics, Inc. | 2001-10-10 |