—#74725

Product

Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K030978
Affected lot / code info: Product Code: 814407R; Lot Code: L65MKD

Why it was recalled

A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.

Root cause (FDA determination)

Process design

Action the firm took

Stryker Important Product Removal Letters were sent via Federal Express on 8/20/2007.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Product went to 2 US Stryker branches.

Timeline

Recall initiated: 2007-08-20
Posted by FDA: 2010-03-16
Terminated: 2010-03-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74725. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.