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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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