Class 2 Device Recall Biomet 2.9j Micromax L15 suture anchor

• Date Initiated by Firm: December 11, 2009
• Date Posted: January 13, 2010
• Recall Status: Terminated on October 18, 2010
• Recall Number: Z-0611-2010
• Recall Event ID: 54114
• 510(K)Number: K040475
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: 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.
• Code Information: Lot 695710.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582
• For Additional Information Contact: 574-267-6639
• Manufacturer Reason for Recall: The anchor label states it contains a flexible shaft, but this lot actually contians a rigid shaft.
• FDA Determined 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 in Commerce: 6
• Distribution: Nationwide Distribution -- Alabama.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HWC