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U.S. Department of Health and Human Services

Class 2 Device Recall Rejuvenate Broach

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  Class 2 Device Recall Rejuvenate Broach see related information
Date Initiated by Firm January 25, 2008
Date Posted September 19, 2008
Recall Status1 Terminated 3 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/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Karen Aremia
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 2
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.