Recall Z-0153-2009 ยท MNI Orthosis, Spinal Pedicle Fixation
Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool; IT-H W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Bender-R; IT-PH1001Power Rod Holder; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight; DM-MR0530 Monoaxial Screw Non-Winged, Size 5 x 30; DM-MR0535 Monoaxial
| Date | Oct 28, 2008 (initiated Aug 21, 2008) |
| Status | Terminated |
| Reason | This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing Practice requirements of the Quality System without any product in the market so it could focus all of its efforts on responding to the FDA. |
| Root cause | Pending |
| Action | Allez Spine issued a field notification beginning August 21, 2008 via FedEx to all its hospital users, distributors and field representatives informing them of their decision to recall the Allez Spine Laguna Pedicle Screw System, Allez Spine Del Mar Pedicle Screw System and the Allez Spine Cross Connectors as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The recall letter requested their customers to return their entire inventory of AlIez Spine manufactured products as soon as possible, gave instruction for product return and provided a contact pe |
| Quantity | 6472 units for all systems |
| Distribution | Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & 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 |