Recall Z-1749-2015 ยท NKB Thoracolumbosacral Pedicle Screw System
Orthofix, Inc
ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse
| Date | Jun 10, 2015 (initiated May 18, 2015) |
| Status | Terminated |
| Reason | The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm. |
| Root cause | Unknown/Undetermined by firm |
| Action | Orthofix sent an Urgent Medical Device Recall Notification letter dated May 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Affected customers were instructed to inspect their inventory, and identify and remove the recalled product to send back to Orthofix. The distributors are also instructed to provide recall notification to hospitals, surgeons, or other distributors that they have further distributed affected product to. Contact your local Orthofix representative or Orthofix customer service representat |
| Quantity | 45 units |
| Distribution | US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130932 | FIREBIRD SPINAL FIXATION SYSTEM Orthofix, Inc., Aug 7, 2013 |