SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect
SpineFrontier, Inc. is recalling 13 PedFuse Reset 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 describes a functional defect (mating issue) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity recall.
Plain-English summary
SpineFrontier, Inc. is recalling 13 units of PedFuse Reset Screw Inserters, specifically the PedFuse Screw Inserter 08-9 REset (Part# 11-80113). These devices are used as a screw capture, screw driver, and screw insertion tool within the PedFuse system.
The recall was initiated because the screw inserters may not mate properly with the hex interface of the screws. This defect could potentially affect the intended function 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 information for the recalled units is VM13222- 34489. Users should stop using these devices and contact SpineFrontier, Inc. for instructions on return or replacement.
The recalled product
- Product
- PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 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
- 13
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)
- VM13222- 34489
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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