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U.S. Department of Health and Human Services

Class 2 Device Recall BIOMET MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE

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  Class 2 Device Recall BIOMET MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE see related information
Date Initiated by Firm September 16, 2011
Date Posted October 20, 2011
Recall Status1 Terminated 3 on March 07, 2013
Recall Number Z-0076-2012
Recall Event ID 59911
Product Classification Guide, surgical, instrument - Product Code FZX
Product MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE, STAINLESS STEEL, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE PO BOX 587 WARSAW IN 46582 USA.

This device is used to mark the femoral neck resection level
Code Information Part 31-555597, lot numbers: 476500, 572420, 663220, 812350, & 472890.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-371-3755
Manufacturer Reason
for Recall		 Biomet has initiated this action following an investigation which identified that the blueprint calls for engraved measurements on both sides on the Microplasty Taperloc 7.5MM Resection Guide. The above lots, as supplied to Biomet by a vendor, are engraved on only one side. To date, Biomet has received 2 reports involving 2 units where the instrument was missing the engraving on one side.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate and discontinue use of the affected product. Arrangements will be made for customers to return the affected product to Biomet. To confirm receipt of this notice call Biomet at 800-348-9500 ext. 3755 or 3756. Questions related to this notice should be directed to 574-371-3755 or 3756, Monday through Friday, 8 AM to 5 PM.
Quantity in Commerce 22
Distribution Worldwide Distribution-USA (nationwide) including the states of AL, CA, IN, MI, OK, and VA and countries of Australia and Chile.
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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