FDA Device recall Z-0555-2014
PedFuse Reset Screw Inserters
- FDA Device
- Class II
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class II recall of PedFuse Reset Screw Inserters by Spinefrontier, citing screw inserters may not mate properly with hex interface of the screws.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0555-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-20 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | FL, IL, NY, OH, TX, VA, WA |
Product
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
Reason
Screw inserters may not mate properly with hex interface of the screws.
Identifiers
| code_info | VM13222- 34489 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Spinefrontier
- A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
FDA Device · Class II · 2019-07-24 · Spinefrontier - SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique
FDA Device · Class II · 2015-04-29 · Spinefrontier - lnline Persuader- PedFuse Pedicle Screw System
FDA Device · Class II · 2015-01-21 · Spinefrontier - SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery
FDA Device · Class II · 2014-05-14 · Spinefrontier - Arena-L 38x28Trial Head I 10¿ Lordotic
FDA Device · Class II · 2014-01-22 · Spinefrontier
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0555-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.