Class 2 Device Recall Scorpio

• Date Initiated by Firm: August 11, 2005
• Date Posted: October 15, 2005
• Recall Status: Terminated on August 15, 2007
• Recall Number: Z-0059-06
• Recall Event ID: 33035
• 510(K)Number: K974556
• Product Classification: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
• 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.
• Code Information: Catalog No. 70-4107R Lot code: K04W896.
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2002
• For Additional Information Contact: Dominick Cristofolo; 201-831-5247
• Manufacturer Reason for Recall: The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.
• FDA Determined Cause: Other
• Action: The recall notification was sent out via FedEx on 8/11/2005 with requested return receipt.
• Quantity in Commerce: 7 units
• Distribution: The product was distributed to their sales representatives/sales agencies, hospitals, and international distribution. The product was shipped to Stryker Germany and Stryker France.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWH