Recall Z-2059-2015 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
Exactech, Inc.
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
| Date | Jul 10, 2015 (initiated Mar 6, 2009) |
| Status | Terminated |
| Reason | Incorrect thread form on the screw. |
| Root cause | Device Design |
| Action | Consignees were notified with a Product Recall Notice on 03/06/2009 that all screws must be checked to ensure that any discrepant products to be removed from the field. |
| Quantity | 749 devices |
| Distribution | Distributed in the states of FL, GA, IL, NY, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051216 | HYDRALOK SYSTEM Altiva Corp., Jul 19, 2005 |