—#70988

Product

Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K962152
Affected lot / code info: Catalog No. 711-4513L; Lot Code: K04S174

Why it was recalled

Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.

Root cause (FDA determination)

Process control

Action the firm took

The International Stryker Distributor was notified via an advisory notice with return receipt on March 18, 2005

Recalling firm

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

Distribution

Distribution pattern: The one unit was distributed to an International Stryker branch.

Timeline

Recall initiated: 2005-03-17
Posted by FDA: 2008-09-16
Terminated: 2008-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70988. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.