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U.S. Department of Health and Human Services

Class 3 Device Recall UltraDriveTool, 6 MM Plug Puller

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  Class 3 Device Recall UltraDriveTool, 6 MM Plug Puller see related information
Date Initiated by Firm April 18, 2012
Date Posted May 10, 2012
Recall Status1 Terminated 3 on April 18, 2013
Recall Number Z-1521-2012
Recall Event ID 61685
510(K)Number K031280  
Product Classification Device, nerve conduction velocity measurement - Product Code JXE
Product Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Biomet Orthopedics, Warsaw, IN 46581

Incorrect Picture Label, Trochanter Plate (50-60 mm) Mallory/Head

The Ultra-DriveTM System is used to aid in the removal of bone cement (PMMA) and noncemented implants in conjunction with revision arthroplasty. The Ultra-Drive" device converts standard electrical energy into mechanical energy, via an ultrasonic transducer in the Ultra-Drive" handpiece. This energy is transmitted through individually tuned tool tips in acoustic waves. causing the tool tip to vibrate at a controlled high speed. This action breaks down bone cement and cuts through cancellous bone.
Code Information Catalog 423868 Lot 409680
Recalling Firm/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Angie Dickson
Manufacturer Reason
for Recall
Incorrect product picture label was on the product box.
FDA Determined
Cause 2
Process design
Action Biomet Orthopedics sent an Urgent Medical Device Recall Notice dated April 18,2012, to all affected customers. The letter identified the reason for the recall including directions to immediately locate, discontinue use of the device, and return product to Biomet, 56 East Bell Drive, Warsaw, IN 46580. Consignees were asked to confirm receipt of the notice by calling 1-800-348-9500 extension 3983 or 3009. A FAX Back Response Form was to be filled out and sent within 3 days of receipt to 574-372-1683. Questions related to the notice should be directed to 474-372-3983 or 574-371-3009, Monday- Friday 8 a.m. to 5 p.m. For questions regarding this recall call 574-371-1021.
Quantity in Commerce 30 units
Distribution Worldwide Distribution - USA (nationwide) and Europe, Austrailia
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.
510(K) Database 510(K)s with Product Code = JXE and Original Applicant = BIOMET, INC.