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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Vanguard Instruments LockOn Femoral Impactor

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 Class 2 Recall
Biomet Vanguard Instruments LockOn Femoral Impactor
see related information
Date Posted January 15, 2010
Recall Status1 Terminated on October 18, 2010
Recall Number Z-0646-2010
Recall Event ID 53945
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery; impactor.
Code Information Lots 122890, 296900, 424590, 433560, 433570, 433580, 433590, 433600, 646610 and 943990.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582
Manufacturer Reason
for Recall
The locking hook tabs may fracture and fragments remain in the patient post-operatively.
FDA Determined
Cause 2
DESIGN: Device Design
Action Urgent Medical Device Recall Notices were sent to distributors on 12/01/2009 with a notice for them to provide to medical facilities where distributor-owned inventory is stored. Distributors were instructed to immediately locate and remove the instruments from circulation; follow the instructions on the "FAX Back Response Form" and fax a copy back prior to returning the product; and to return the product to the firm. Questions should be directed to 800-348-9500.
Quantity in Commerce 92
Distribution Worldwide Distribution -- USA, Canada, China, Costa Rica, Denmark, Germany, Netherlands, New Zealand, and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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