Recall Z-1881-2016 ยท HXX Screwdriver
Orthofix, Inc
Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
| Date | Jun 1, 2016 (initiated Apr 27, 2016) |
| Status | Terminated |
| Reason | There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle. |
| Root cause | Device Design |
| Action | Affected distributors will be provided a written notification of field correction via USPS Certified Mail or FedEx on 4/27/16. Distributors will be additionally instructed to provide field correction notifcations to hospitals, surgeons, or other distributors that they may have further ditributed the product to. |
| Quantity | 36 units |
| Distribution | KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System Orthofix, Inc., Jan 29, 2016 |