Recall Z-0611-2010 ยท HWC Screw, Fixation, Bone
Biomet, Inc.
Biomet 2.9 Micromax L-15 suture anchor, flexible long shaft, #2 blue/white maxbraid, PLLA/PGA L-15, sterile, Biomet Sports Medicine, Warsaw, IN; REF 905456. Intended for use in soft tissue reattachment procedures in the shoulder, wrist, elbow and knee.
| Date | Jan 13, 2010 (initiated Dec 11, 2009) |
| Status | Terminated |
| Reason | The anchor label states it contains a flexible shaft, but this lot actually contians a rigid shaft. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 6 |
| Distribution | Nationwide Distribution -- Alabama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040475 | MICROMAX SUTURE ANCHOR Biomet, Inc., May 21, 2004 |