Class 2 Device Recall Osteonics Scorpio Total Knee

• Date Initiated by Firm: March 17, 2005
• Date Posted: September 16, 2008
• Recall Status: Terminated on September 24, 2008
• Recall Number: Z-2079-2008
• Recall Event ID: 48199
• 510(K)Number: K962152
• Product Classification: Patellofemorotibial knee prosthesis - Product Code JWH
• 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.
• Code Information: Catalog No. 711-4513L; Lot Code: K04S174
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2002
• For Additional Information Contact: Colleen O'Meara; 201-831-5000
• Manufacturer Reason for Recall: Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.
• FDA Determined Cause: Process control
• Action: The International Stryker Distributor was notified via an advisory notice with return receipt on March 18, 2005
• Quantity in Commerce: 1 unit
• Distribution: The one unit was distributed to an International Stryker branch.
• 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