Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009, 1601-1010 Stryker Orthopaedics, Mah
FDA device recall Z-2349-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.
- Action taken
- 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
- Status
- Terminated
- Product code
- HTQ
- Quantity affected
- 78 devices
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-01-25
- Date posted
- 2008-09-19
- Date terminated
- 2008-09-22
- Location
- Mahwah, NJ
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