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U.S. Department of Health and Human Services

Class 2 Device Recall Vanguard Distal Cut Block

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 Class 2 Recall
Vanguard Distal Cut Block
see related information
Date Posted March 19, 2012
Recall Status1 Terminated on November 06, 2012
Recall Number Z-1222-2012
Recall Event ID 61274
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Vanguard Knee Instrumentation Distal Cutting Block without Handles, REF 32-487002 LOT 2561329, Biomet UK Ltd, South Wales, UK Used to guide a saw blade in resecting the the distal femor. Intended to be used with a femoral alignment guide guide.
Code Information REF 32-487002, Lot 2561329
Recalling Firm/
Manufacturer
Biomet U.K., Ltd.
Waterton Industrial Estate
Bridgend, South Wales
For Additional Information Contact Richard Young
1656-761658
Manufacturer Reason
for Recall
This recall was initiated following a report that a bag labeled as REF. 32-487557/Lot no 2561334 (Vanguard Tibial Resection head universal w/ alignment tower) actually contained a Ref. 32-487002/Lot no. 2561329 (Vanguard Distal cutting Block w/out handle attachment). Investigation found packaging of the affected product may contain the incorrect item.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control
Action Biomet U.K. sent a Field Safety Corrective Action notice dated February 14, 2012 to all affected customers. The notice identified the affected products, problem and actions to be taken. Customers were instructed to locate, discontinue use and quarantine the recalled products pending return to Biomet. The letter recommended customers provide the notice to any other organization who may have received the affected instruments. Customers were instructed to complete and return without delay the attached "Fax-Back Response Form" acknowledging receipt of notice and indicating the quantity of products to be returned. For questions call +44 (0) 1656 761658, fax: +44 (0) 1656 645454 and e-mail uk.complaints@biomet.com.
Quantity in Commerce 4 units
Distribution Worldwide Distribution - in the countries of France, Japan, Italy, Netherlands, UK , no devices distributed in the USA
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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