Recall Z-1819-2008 ยท MNI Orthosis, Spinal Pedicle Fixation
Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Number: 54003); IT-FN1002, Laguna Sterilization Tray # 2 (Part Number: 54004)
| Date | Sep 2, 2008 (initiated Apr 14, 2008) |
| Status | Terminated |
| Reason | This field action was initiated because the cleaning, decontamination and sterilization procedures specified in the "Instructions for Use" for the impacted systems are incorrect. The use of these parameters in performing cleaning, decontamination and sterilization procedures may not result in clean and sterile product. |
| Root cause | Error in labeling |
| Action | Allez Spine issued a safety notice with attached fax-back attachment on April 14, 2008 via FedEx to all its hospital users, distributors and field representatives informing them of the failure of the sterilization validation and requesting them to use the new recommended sterilization parameters. The notice included copies of the updated Instructions for Use for the Allez Spine Laguna Pedicle Screw System and the Allez Spine Del Mar Pedicle Screw System. The safety notice requested that the revised recommended instructions be used for all future cleaning, decontamination and sterilization. Cop |
| Quantity | 64 systems |
| Distribution | Nationwide to 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 |