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Class 2 Device Recall Biomet 2.9j Micromax L15 suture anchor |
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Date Initiated by Firm |
December 11, 2009 |
Date Posted |
January 13, 2010 |
Recall Status1 |
Terminated 3 on October 18, 2010 |
Recall Number |
Z-0611-2010 |
Recall Event ID |
54114 |
510(K)Number |
K040475
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Product Classification |
Screw, fixation, bone - Product Code HWC
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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
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For Additional Information Contact |
574-267-6639
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Manufacturer Reason for Recall |
The anchor label states it contains a flexible shaft, but this lot actually contians a rigid shaft.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = HWC and Original Applicant = BIOMET, INC.
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