Recall Z-1674-2011 ยท NKB Thoracolumbosacral Pedicle Screw System
Orthofix Inc
BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self Tapping, Cannulated. The Multi-Axial Screw is a pedicle screw which is inserted into the pedicle with the use of the Multi-Axial Screw Driver. The component is used within the Firebird Spinal Fixa
| Date | Mar 16, 2011 (initiated Oct 22, 2010) |
| Status | Terminated |
| Reason | There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance. |
| Root cause | Other |
| Action | Orthofix sent an URGENT: PRODUCT RECALL letter dated October 22, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their accounts immediately and advise them of the recall situation and have them return any affected inventory. For any questions customers were instructed to contact their Account Services Representative at 1-888-298-5700. For questions regarding this recall call 214-937-2061. |
| Quantity | 27 (19 of 77-7630) (8 of 77-8630) |
| Distribution | Nationwide Distribution including AZ, NY, TX, MS, LA, FL, NC, and AR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081684 | BLACKSTONE PEDICLE SCREW SYSTEM Blackstone Medical, Inc., Sep 15, 2008 |