Z-2349-2008

Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009, 1601-1010 Stryker...

Name: Z-2349-2008 Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009, 1601-1010 Stryker...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-01-25
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-01-25 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009, 1601-1010 Stryker Orthopaedics, Mahwah, NJ. 07430 Contours the proximal... on 2008-01-25. The reason FDA records is "Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2349-2008
Status: Terminated
Initiated: 2008-01-25
Posted: 2008-09-19
Terminated: 2008-09-22
Recalling firm: Howmedica Osteonics Corp
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.
Product code: HTQ Broach
Reason for recall: Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.
Root cause tag: design
FDA root 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.
Product codes and lots: All Lot Codes

Product code HTQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)