Recalls / —
—#69049
Product
Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.
- FDA product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K974556
- Affected lot / code info
- Lot Number: K04W966.
Why it was recalled
Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component.
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- Worldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK.
Timeline
- Recall initiated
- 2005-02-08
- Posted by FDA
- 2008-07-16
- Terminated
- 2008-07-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #69049. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.