SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect
SpineFrontier, Inc. is recalling 25 PedFuse Screw Inserters because they may not mate properly with the hex interface of the screws.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a functional defect (improper mating) without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
SpineFrontier, Inc. is recalling 25 units of PedFuse Reset Screw Inserters, including the PedFuse Screw Inserter 05-7 REspond (Part# 11-80111), Screw Inserter 05-7 REset, and Screw Inserter 08-9 REset. These devices are used as screw capture, screw driver, and screw insertion tools within the PedFuse system.
The recall is being conducted because the screw inserters may not mate properly with the hex interface of the screws. This defect could potentially affect the functionality of the device during use.
The affected units were distributed in the United States to Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. The specific code for the recalled units is VM 13194-34457. Users of these devices should contact SpineFrontier, Inc. for further instructions on how to proceed.
The recalled product
- Product
- PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 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.
- Manufacturer
- SpineFrontier, Inc.
- Hazard
- Affected units
- 25
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- VM 13194-34457
Distribution
Part of a larger recall action
This product is one of 3 recalled by SpineFrontier, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · SpineFrontier, Inc.
See all →- HighSpineFrontier Recalls A-CIFT SoloFuse Fixed Angle Driver Due to Binding Risk
FDA (Devices) · 2019-07-24
- ModerateSpineFrontier Recalls MISquito Pedicle Screw System Surgical Technique Document
FDA (Devices) · 2015-04-29
- HighSpineFrontier Recalls Inline Persuader Pedicle Screw System Due to Handle Crack
FDA (Devices) · 2015-01-21
- SevereSpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage
FDA (Devices) · 2014-05-14
- ModerateSpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues
FDA (Devices) · 2014-01-22
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07