FDA Device recall Z-0797-2016
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation…
- FDA Device
- Class II
- terminated
- Published 2016-02-17
On 2016-02-17 the FDA classified a Class II recall of Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation… by Orthofix, citing 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 ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0797-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-08 |
| Published | 2016-02-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orthofix |
| Distribution | n/a |
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
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.
Identifiers
| code_info | BS535418105, BS535419118, BS535420030, BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS5354…BS535418105, BS535419118, BS535420030, BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS535418012, BS535419006, BS535420039, BS535418127, BS549024010, BS535419141, BS535418081, BS535418111, BS535418117, BS535420041, BS535418144, BS535420081, BS535419151, BS562325006, BS546825008, BS535418002, BS535418013, BS535418131, BS535420006, BS535420010, BS535420026, BS535420047, BS556219012, BS556219026, BS535418109, BS535420082, BS557717009, and BS562325023. |
|---|
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-0797-2016%22
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