Class 2 Device Recall Scorpio NRG

• Date Initiated by Firm: August 20, 2007
• Date Posted: March 16, 2010
• Recall Status: Terminated on March 16, 2010
• Recall Number: Z-1141-2010
• Recall Event ID: 50102
• 510(K)Number: K030978
• Product Classification: knee prosthesis - Product Code JWH
• Product: Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ
• Code Information: Product Code: 814407R; Lot Code: L65MKD
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430
• For Additional Information Contact: Rich Wolyn; 201-831-5158
• Manufacturer Reason for Recall: A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.
• FDA Determined Cause: Process design
• Action: Stryker Important Product Removal Letters were sent via Federal Express on 8/20/2007.
• Quantity in Commerce: 4 units
• Distribution: Product went to 2 US Stryker branches.
• 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