FDA Device recall Z-0855-2014
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for insertin…
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for insertin… by Orthofix, citing orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complain….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0855-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-26 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Orthofix |
| Distribution | US |
Product
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
Reason
Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws, which may result in a delay of surgery.
Identifiers
| code_info | Production Identification Numbers: Part Number 52-1332, All Lot Numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0855-2014%22
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