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U.S. Department of Health and Human Services

Class 2 Device Recall Intramedullary Bone Saw

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 Class 2 Device Recall Intramedullary Bone Sawsee related information
Date Initiated by FirmFebruary 26, 2014
Date PostedMarch 20, 2014
Recall Status1 Terminated 3 on July 07, 2015
Recall NumberZ-1243-2014
Recall Event ID 67618
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductPart 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
Code Information Lot 239430, 239450 
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information ContactAudrey Daenzer
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.
FDA Determined
Cause 2		Labeling False and Misleading
ActionThe firm, BIOMET, sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter dated February 26, 2014 via Fed Ex overnight to domestic consignees. Australia and GSCC were notified by email and also received a hard copy letter via mail. The letter described the product, problem and actions to be taken. The letter stated that this action requires the immediate location and discontinued use of the product and its return to Biomet. The Consignees were were instructed to immediately locate, discontinue use of the product and remove the identified device(s) listed; carefully follow the instructions on the FAX Back Response Form and reply within three (3) business days; complete and return Form via Fax to: 574-372-1683 prior to return of product, and use priority carrier for your shipment. If you have further distributed this product, you MUST notify hospital personnel of this action via enclosed "Dear Risk/Recall Manager Notice", and note that you are charged with the location and return of these products. Shipping address is Return Goods, 56 E. Bell Drive Warsaw, IN 46582. Questions related to the notice should be directed to 574-372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in Commerce10
DistributionWorldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
Total Product Life CycleTPLC 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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