Recall Z-2066-2008 ยท MNI Orthosis, Spinal Pedicle Fixation
Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 50mm, Non-winged, Catalog # LG-PR0650
| Date | Sep 17, 2008 (initiated Nov 7, 2007) |
| Status | Terminated |
| Reason | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. |
| Root cause | Device Design |
| Action | Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory. All customers and consignees were contacted by the firm. |
| Quantity | 1 |
| Distribution | Nationwide to AZ, CA, CO & UT |
| FDA record | Open on fda.gov |