Recall Z-0190-2008 ยท MNI Orthosis, Spinal Pedicle Fixation
Allez Spine, LLC
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 55, Catalog Number LG-PR0855, Allez Spine, LLC., Irvine, CA
| Date | Mar 11, 2008 (initiated Jul 30, 2007) |
| Status | Terminated |
| Reason | Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation. |
| Root cause | Device Design |
| Action | On July 30, 2007 Allez Spine notified all its field representatives and distributors via email of a potential for failure of the Size 8 Pedicle Screws when used in combination with the single piece locking nuts and instructed them to return all unused inventory of Size 8 Screws and the two piece Locking Nuts with saddle. This action was to be carried out to the retail level-hospital, clinic, lab, and physicians sold the product. The email also had an attachment of a list of expected frequently asked questions (FAQ) from surgeons and answers to help them respond. A second Notice to all users wa |
| Quantity | 305 |
| Distribution | Nationwide: including the states of AZ, CA, CO, GA, NV, TX and UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050060 | LAGUNA PEDICLE SCREW SYSTEM Allez Spine, LLC, May 4, 2005 |