Stryker Howmedica Osteonics Corp. 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. Recall
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According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Stryker Howmedica Osteonics Corp.
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Stryker Howmedica Osteonics Corp. is recalling Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009, 1601-1010 Stryk due to Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026