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.
FDA Recall Z-0611-2010 · Posted 2010-01-13
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2009-12-11
Date Terminated2010-10-18
Product Quantity6
Reason for Recall
The anchor label states it contains a flexible shaft, but this lot actually contians a rigid shaft.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution -- Alabama.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.