Recalls / —
—#64416
Product
Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116.
- 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 918930; 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 #64416. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.