Class 2 Device Recall Biomet Vanguard Width Checker

• Date Initiated by Firm: February 12, 2008
• Date Posted: March 28, 2008
• Recall Status: Terminated on June 26, 2009
• Recall Number: Z-1362-2008
• Recall Event ID: 46706
• Product Classification: Template for Clinical Use - Product Code HWT
• Product: Biomet Vanguard Knee Instrumentation, Part Number: 32-487062, 67.5/70/75mm Sizing Wing, Biomet UK Ltd, Made in Britain; The device is a preparatory instrument used for femoral knee insertion. (Distributed to Puerto Rico).
• Code Information: Lot Number-1162107
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46581-0587
• For Additional Information Contact: 800-348-9500
• Manufacturer Reason for Recall: The instrument's sizing line is in the wrong place.
• FDA Determined Cause: Process control
• Action: Distributors were notified via Urgent Medical Device Removal Notice letter dated 2/12/08 to locate the instruments in their possession and at hospital sites and to return them to Biomet. Hospitals with the instruments on hand will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. The Puerto Rico consignee was notified by Biomet UK, Ltd. via letter on 2/26/08.
• Quantity in Commerce: 1
• Distribution: Worldwide: USA, Canada, China and Finland.
• 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.