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U.S. Department of Health and Human Services

Class 2 Device Recall VANGUARD MP SLIDEX AP SIZER

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  Class 2 Device Recall VANGUARD MP SLIDEX AP SIZER see related information
Date Initiated by Firm February 10, 2011
Date Posted March 28, 2011
Recall Status1 Terminated 3 on May 16, 2011
Recall Number Z-1833-2011
Recall Event ID 58025
Product Classification Guide, surgical, instrument - Product Code FZX
Product REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1

The guide is used for femoral sizing - Neutral or 3 degree femoral rotation feet are attached to the slidex AP sizing guide.
Code Information LOT 32-485050 LOT NO. SA10 81254
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
Manufacturer Reason
for Recall		 Biomet has initiated this action due to the scale on the stylus of the Vanguard MP Slldex AP Sizer being incorrect for this assembly resulting in the scale being out of position.
FDA Determined
Cause 2		 Process change control
Action The firm, Biomet, sent a "FIELD SAFETY NOTICE" dated February 11, 2011 to all customers (heads of Orthopaedic Departments/Operating Departments /Sterile Services Departments/Procurement /Supplies/ Risk Management). The notice described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the product; return to Biomet or their local Biomet distributor; ensure that the operating staff are made aware of this issue, and complete and return the FAX BACK RESPONSE FORM to Biomet UK Ltd or their local Biomet distributor via fax at +44 (0) 1656 645454. If you have any questions regarding this communication, please contact the Regulatory & Compliance Manager at +44 (0) 1793 645317 or email: edward.spearpoint@biometeurope.com.
Quantity in Commerce 17
Distribution Foreign only; UK, Malta, The Netherlands, Italy, Turkey, Switzerland.
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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