Biomet 2.9 Micromax L-15 suture anchor, flexible long shaft, #2 blue/white maxbraid, PLLA/PGA L-15, sterile, Biomet Spor
FDA device recall Z-0611-2010 · posted 2010-01-13 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The anchor label states it contains a flexible shaft, but this lot actually contians a rigid shaft.
- Action taken
- Biomet Sports Medicine notified the single consignee by letter dated December 11, 2009. The firm requested that users locate and return the affected product and return a business reply card. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 6
- Distribution
- Nationwide Distribution -- Alabama.
- Date initiated
- 2009-12-11
- Date posted
- 2010-01-13
- Date terminated
- 2010-10-18
- 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 |
|---|---|---|
| MICROMAX SUTURE ANCHOR (K040475) | Biomet, Inc. | 2004-05-21 |