Class 2 Device Recall Microplasty Elite Instruments Vanguard Femoral Cutting Blocks

• Date Initiated by Firm: December 18, 2008
• Date Posted: January 13, 2009
• Recall Status: Terminated on January 20, 2010
• Recall Number: Z-0876-2009
• Recall Event ID: 50698
• Product Classification: Manual Surgical Instrument for General Use - Product Code HTZ
• Product: Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 62.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485153. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
• Code Information: Lots 083830, 132502 and 132503.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582
• For Additional Information Contact: 800-348-9500
• 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: Other
• 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.