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U.S. Department of Health and Human Services

Class 2 Device Recall Microplasty Elite Instruments Vanguard Femoral Cutting Blocks

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  Class 2 Device Recall Microplasty Elite Instruments Vanguard Femoral Cutting Blocks see related information
Date Initiated by Firm December 18, 2008
Date Posted January 13, 2009
Recall Status1 Terminated 3 on January 20, 2010
Recall Number Z-0874-2009
Recall Event ID 50698
Product Classification Manual Surgical Instrument for General Use - Product Code HTZ
Product Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485151. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
Code Information Lots 083730 and 132302.
Recalling Firm/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact
Manufacturer Reason
for Recall
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
FDA Determined
Cause 2
Action Consignees were notified by letter entitled "URGENT MEDICAL DEVICE REMOVAL NOTICE" dated 12/18/08 advising them of the problem and that the instruments should be removed from use and returned. For further information, please contact Biomet, Inc., by telephone on 800-348-9500.
Quantity in Commerce 444 of all products
Distribution Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
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.