Recall Z-0797-2016 ยท HXC Wrench
Orthofix, Inc
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
| Date | Feb 11, 2016 (initiated Jan 8, 2016) |
| Status | Terminated |
| Reason | There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention. |
| Root cause | Component design/selection |
| Action | Affected consignees were notified via an Urgent Medical Device Recall Notification letter, dated 1/8/16. The letter identified the affected device and stated the reason for the recall. The recalling firm requests customers to remove the affected devices from their inventory and cease further distribution or use. Customers whom the devices were further distributed to should be notified that the affected devices cannot be used and must be returned to Orthofix per the instructions provided. The attached Acknowledgement Form should be completed and returned. Customers can contact their local |
| Quantity | 36 units |
| Distribution | Worldwide Distribution -- US, Spain, Italy, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Orthofix, Inc., Jul 7, 2015 |