—#41231

Product

Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.

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: Catalog No. 70-4107R Lot code: K04W896.

Why it was recalled

The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.

Root cause (FDA determination)

Other

Action the firm took

The recall notification was sent out via FedEx on 8/11/2005 with requested return receipt.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: The product was distributed to their sales representatives/sales agencies, hospitals, and international distribution. The product was shipped to Stryker Germany and Stryker France.

Timeline

Recall initiated: 2005-08-11
Posted by FDA: 2005-10-15
Terminated: 2007-08-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41231. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.