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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Vanguard Width Checker

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  Class 2 Device Recall Biomet Vanguard Width Checker see related information
Date Initiated by Firm February 12, 2008
Date Posted March 28, 2008
Recall Status1 Terminated 3 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 2		 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.
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