Recalls / —
—#72727
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.
- FDA product code
- HTQ — Broach
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- All Lot Codes
Why it was recalled
Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2008-01-25
- Posted by FDA
- 2008-09-19
- Terminated
- 2008-09-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #72727. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.