• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Biomet 2.9j Micromax L15 suture anchor

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Biomet 2.9j Micromax L15 suture anchor see related information
Date Initiated by Firm December 11, 2009
Date Posting Updated January 13, 2010
Recall Status1 Terminated 3 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/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact
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
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 and Original Applicant = BIOMET, INC.