Class 2 Device Recall Rejuvenate Broach

• Date Initiated by Firm: January 25, 2008
• Date Posted: September 19, 2008
• Recall Status: Terminated on September 22, 2008
• Recall Number: Z-2349-2008
• Recall Event ID: 49087
• Product Classification: Broach - Product Code HTQ
• Product: Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009, 1601-1010 Stryker Orthopaedics, Mahwah, NJ. 07430 Contours the proximal femur to the geometry of the stem to provide a complimentary fit of the stem to the bone.The broaches are designed with a series of teeth that are intended to seat against highly densified cancellous bone for the interference press-fit in the uncemented application.
• Code Information: All Lot Codes
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2002
• For Additional Information Contact: Karen Aremia; 201-831-5000
• Manufacturer Reason for Recall: Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.
• FDA Determined Cause: Device Design
• Action: Stryker notified all branches and agencies to return the product on January 25, 2008. A formal recall letter was not written as all product was in their control.
• Quantity in Commerce: 78 devices
• Distribution: Nationwide Distribution.
• 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.