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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Exact Calcar Planer Rasp Style Blade

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  Class 2 Device Recall Biomet Exact Calcar Planer Rasp Style Blade see related information
Date Initiated by Firm July 18, 2008
Date Posted September 29, 2008
Recall Status1 Terminated 3 on June 26, 2009
Recall Number Z-2371-2008
Recall Event ID 49013
Product Classification Blade - Product Code GFA
Product Exact Calcar Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473796. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.
Code Information Lots 010180, 865890, 439380, 850170 and 918020.
Recalling Firm/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581-0587
For Additional Information Contact
800-348-9500 Ext. 3983
Manufacturer Reason
for Recall
The blades will oxidize after the first cleaning.
FDA Determined
Cause 2
Process control
Action Distributors were notified via letter dated 7/18/08 to locate and remove the products and to return them. Distributors were instructed to conduct the recall to the hospital level and to notify the hospitals of the recall by copy of an undated recall letter. Contact Biomet, Inc. at 1-800-348-9500, ext. 3983 for assistance.
Quantity in Commerce 141 of all products
Distribution Nationwide and China.
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.