FDA Recall
Terminated
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.
Recall: Z-0611-2010
·
Initiated December 11, 2009
Recall
- Recall Number
- Z-0611-2010
- Event Number
- 54114
- Firm
- Biomet, Inc.
- FEI Number
- 1825034
- Product Code
- HWC
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- December 11, 2009
- Posted
- January 13, 2010
- Terminated
- October 18, 2010
- Address
- 56 E Bell Dr, Warsaw, IN, 46582
Description
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.
Reason
The anchor label states it contains a flexible shaft, but this lot actually contians a rigid shaft.
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.
Distribution
Nationwide Distribution -- Alabama.
Quantity
6