Exact Calcar Planer Rasp Style Blade, 50mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473798. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.
FDA Recall Z-2373-2008 · Posted 2008-09-29
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeGFA
Date Initiated2008-07-18
Date Terminated2009-06-26
Product Quantity141 of all products
Reason for Recall
The blades will oxidize after the first cleaning.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide and China.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.