—#64415

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.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K921182
Affected lot / code info: Lot 311500; exp. 2012-02.

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern: Class II Recall - Worldwide Distribution --- USA including states of IA, SD, and countries of Brazil and Chile.

Timeline

Recall initiated: 2007-07-24
Posted by FDA: 2007-10-31
Terminated: 2008-07-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64415. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.