Firebird Spinal Fixation System Torque Limiting Handle — Class II medical device recall Z-0797-2016
Terminated recall by Orthofix, Inc, reported 2016-02-17. There is a possibility that the device may deliver a torque value less than the required setting after initial
| Recall number | Z-0797-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix, Inc, Lewisville, TX, United States |
| Recall initiated | 2016-01-08 |
| Classified | 2016-02-10 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2016-11-16 |
| Countries outside the US | AU, ES, IT |
| Quantity | 36 units |
Product
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
Reason for recall
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.
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-0797-2016. 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.