FDA Device recall Z-1881-2016
Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct by Orthofix, citing 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 ha….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1881-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-27 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orthofix |
| Distribution | AZ, CA, FL, ID, KS, MA, MI, NH, NJ, NV, SC, TX, UT, WA |
Product
Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
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.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1881-2016%22
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