SpineFrontier Recalls PedFuse Reset Pedicle Screws Due to Assembly Error
SpineFrontier, Inc. is recalling 35 PedFuse Reset pedicle screws because one unit was found assembled with the wrong size screw. The recall covers devices distributed to Virginia and Texas.
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. The source describes a manufacturing assembly error (wrong screw size) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a potential defect without confirmed harm.
Plain-English summary
SpineFrontier, Inc. is recalling 35 units of the PedFuse Reset pedicle screw, Model 01-80115-55. These implants are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The affected lot number is 357305-000.
The recall was initiated after routine servicing revealed that one 8mmx55mm Reset screw was incorrectly assembled with an 8mm tulip head and a 9mm screw, rather than the required 8mm tulip head and 8mm screw. The company is removing all remaining screws of the same lot from the field to investigate this nonconformity.
The affected devices were distributed in the United States to Virginia and Texas. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate action, but the devices are being removed from the field.
The recalled product
- Product
- PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
- Manufacturer
- SpineFrontier, Inc.
- Affected units
- 35
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)
- Lot/Serial Numbers: 357305-000
Distribution
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