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U.S. Department of Health and Human Services

Class 2 Device Recall Cylindrical Reamer

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  Class 2 Device Recall Cylindrical Reamer see related information
Date Initiated by Firm December 23, 2010
Date Posted March 04, 2011
Recall Status1 Terminated 3 on October 01, 2012
Recall Number Z-1537-2011
Recall Event ID 57605
Product Classification Reamer - Product Code HTO
Product Cylindrical Bullet Nose Reamer 13.0 mm x 250 mm, REF 475814, Biomet Orthopedics 66 East Bell Drive Warsaw IN.

The product is used to prepare the femoral canal for stem implantation.
Code Information 180900 and 957590
Recalling Firm/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall
The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.
FDA Determined
Cause 2
Action The firm, BIOMET, sent an" URGENT MEDICAL DEVICE RECALL NOTICE" dated December 23, 2010 to its customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to immediately locate, discontinue use of product and return the product to Biomet. Biomet distributors were told to notify hospital personnel of the recall if they had distributed the product to hospital customers. The Customers/Distributors were instructed to confirm receipt of the notice by calling 800-348-9500 extension 3755 and 3983 and to complete and return the Response Form included with the recall notice via fax to 574-372-1683. Questions related to this notice should be directed to 574-371-3755 or 574-372-3983, Monday through Friday, 8am to 5pm.
Quantity in Commerce 51 all products
Distribution Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
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.