Recall Z-1554-05 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
Stryker Howmedica Osteonics Corp.
The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of degenerative Spondylolisthesis.
| Date | Sep 21, 2005 (initiated May 16, 2005) |
| Status | Terminated |
| Reason | The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence. |
| Root cause | Other |
| Action | The notification letters and product accountability forms were sent to their branches/agencies and the one hospital via Fedex on 5/16/2005 with return receipt. |
| Quantity | 107 |
| Distribution | Stryker distributes their product though branches/agencies and occassionally directly to hospitals. These branches/agencies are located nationwide and will deliver the device to the medical facility. There are 31 branches and 1 hospital involved. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.