Firebird NXG Spinal Fixation System Set Screw Driver used to insert a… — Class II medical device recall Z-1881-2016
Terminated recall by Orthofix, Inc, reported 2016-06-08, distributed in AZ, CA, FL, ID, KS, MA, MI, NH…. There is a possibility that the subject set screw driver could disengage from the torque limiting handle when
| Recall number | Z-1881-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix, Inc, Lewisville, TX, United States |
| Recall initiated | 2016-04-27 |
| Classified | 2016-06-01 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2016-11-23 |
| Distributed | AZ, CA, FL, ID, KS, MA, MI, NH, NJ, NV, SC, TX, UT, WA |
| Quantity | 36 units |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1881-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.