Recalls / —
—#64412
Product
Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Biomet Orthopedics, Inc., Warsaw, IN 46581
- FDA product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K023546
- Affected lot / code info
- Lot Number: 395450.
Why it was recalled
Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.
Root cause (FDA determination)
Packaging process control
Action the firm took
Biomet notified consignees via letter dated 8/31/07, titled Urgent Medical Device Recall Notice to immediately discontinue use of the product and to return units to Biomet.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46581-0587
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2007-08-31
- Posted by FDA
- 2007-12-05
- Terminated
- 2008-06-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #64412. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.