Class 2 Device Recall Howmedica Osteonics

• Date Initiated by Firm: July 17, 2003
• Date Posted: August 21, 2003
• Recall Status: Terminated on September 03, 2003
• Recall Number: Z-1143-03
• Recall Event ID: 26863
• Product Classification: Instrument, Cutting, Orthopedic - Product Code HTZ
• Product: Femoral Resection Guide, Scorpio L.R.S. Instrumentation.
• Code Information: Catalog No: 8050-5103; 8050-5105; 8050-5107; 8050-5109; 8050-5111; 8050-5113.
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics; 300 Commerce Court; Mahwah NJ 07430
• For Additional Information Contact: Dominick Cristofolo; 201-831-5247
• Manufacturer Reason for Recall: Scorpio Femoral Resection Guides have the potential to remove more bone than necessary.
• FDA Determined Cause: Other
• Action: Product recall letters and product accountability forms were sent via FedEx to all Branches/sales agents on July 17, 2003. For the Canadian and International customers, the recall notification was also sent on July 17, 2003. All devices are to be returned to Howmedica Osteonics, Mahwah, NJ.
• Quantity in Commerce: 102
• Distribution: The catalog numbers were sent to Howmedica Osteonics Sales Representatives/agents, one Canada Howmedica Sales Representative, and one International Howmedica location in Ireland.
• 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.