FDA Device recall Z-0624-2014
PedFuse Bone Probe
- FDA Device
- Class II
- terminated
- Published 2014-01-15
On 2014-01-15 the FDA classified a Class II recall of PedFuse Bone Probe by Spinefrontier, citing bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0624-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-11 |
| Published | 2014-01-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | TX, VA |
Product
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Reason
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
Identifiers
| code_info | Lot: 012212-001 |
|---|
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-0624-2014%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.