Recalls / —
—#99936
Product
Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141232, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.
- FDA product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- Affected lot / code info
- REF 141232, LOT J100927055
Why it was recalled
The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".
Root cause (FDA determination)
Packaging process control
Action the firm took
Biomet Orthopedics Inc initiated an electronic communication with Direct Accounts on March 3, 2011 and instructed them to quarantine and return all remaining/unused devices to the firm. For questions regarding this recall call 574-372-3983.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582
Distribution
- Distribution pattern
- Worldwide Distribution -USA including FL, IN, and NC and the countries of Japan and the Netherlands
Timeline
- Recall initiated
- 2011-03-03
- Posted by FDA
- 2011-04-28
- Terminated
- 2011-07-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #99936. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.