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Z-0076-2008

Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior...

Zimmer GmbH / initiated 2007-07-24 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Biomet, Inc. began a recall of 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... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0076-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
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.
Product code
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag
labeling and UDI
FDA root cause
Labeling mix-ups
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.
Quantity in commerce
4
Distribution
Class II Recall - Worldwide Distribution --- USA including states of IA, SD, and countries of Brazil and Chile.
Product codes and lots
Lot 311500; exp. 2012-02.