Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Biomet Orthopedic, Inc.
FDA Recall Z-0076-2008 · Posted 2007-10-31
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2007-07-24
Date Terminated2008-07-24
Product Quantity4
Reason for Recall
Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.
Firm Action
The firm notified distributor by phone on or about 7/24/07 and followed up with an Urgent Medical Device Recall Notice/Letter dated 8/31/07. The letter requested that the product be discontinued and returned to Biomet.
Root Cause
Labeling mix-ups
Distribution Pattern
Class II Recall - Worldwide Distribution --- USA including states of IA, SD, and countries of Brazil and Chile.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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