Recall Z-2349-2008 ยท HTQ Broach
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
| Date | Sep 19, 2008 (initiated Jan 25, 2008) |
| Status | Terminated |
| Reason | Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture. |
| 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 | 78 devices |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.