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Terminated

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.

FDA Recall Z-2349-2008 · Posted 2008-09-19

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHTQ
Date Initiated2008-01-25
Date Terminated2008-09-22
Product Quantity78 devices

Reason for Recall

Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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