FDA Device recall Z-1927-2013
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(…
- FDA Device
- Class II
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class II recall of Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(… by Spinefrontier, citing device design.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1927-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-10 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | US |
Product
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
Reason
Device design.
Identifiers
| code_info | Lot/Serial Numbers: 027104, 027105 |
|---|
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-1927-2013%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.