—#74724

Product

Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics. Intended for cemented application to replace the articulating surface of the distal femur.

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: Scorpio (no post) with LFIT: Product code 72-4107-L; Lot code: JKWMHD;

Why it was recalled

Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Stryker Orthopaedics issued an "Important Product Removal" letter via Federal Express dated July 30, 2007 to all direct accounts. Users were asked to identify and return all affected product to the firm. For further information, contact Stryker Orthopaedics at (201) 831-5825.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- United States and France.

Timeline

Recall initiated: 2007-07-30
Posted by FDA: 2010-02-19
Terminated: 2010-02-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74724. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.