Recalls / —
—#65272
Product
Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN 46582
- FDA product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K915132
- Affected lot / code info
- Lot 626520.
Why it was recalled
Mislabeled as to size: the package actaully contained a 71 mm tray.
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
Consignees were notified via letter dated 9/18/07 to discontinue use of the product and to return it to the firm.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46581-0587
Distribution
- Distribution pattern
- Nationwide : Distributors in Georgia, Kentucky, Texas and Washington.
Timeline
- Recall initiated
- 2007-09-18
- Posted by FDA
- 2007-11-24
- Terminated
- 2008-06-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #65272. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.