FDA Device recall Z-1479-2015
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique
- FDA Device
- Class II
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class II recall of SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique by Spinefrontier, citing the PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1479-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-05 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | US |
Product
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
Reason
The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
Identifiers
| code_info | Revision E |
|---|
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 - 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 - Arena-L Trial Handle
FDA Device · Class II · 2014-01-22 · Spinefrontier
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1479-2015%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.