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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet 2.9j Micromax L15 suture anchor

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 Class 2 Recall
Biomet 2.9j Micromax L15 suture anchor
see related information
Date Posted January 13, 2010
Recall Status1 Terminated on October 18, 2010
Recall Number Z-0611-2010
Recall Event ID 54114
Premarket Notification
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, Indiana 46582
Manufacturer Reason
for Recall
The anchor label states it contains a flexible shaft, but this lot actually contians a rigid shaft.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = BIOMET, INC.
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