SpineFrontier Recalls Inline Persuader Pedicle Screw System Due to Handle Crack
SpineFrontier, Inc. is recalling four Inline Persuader PedFuse Pedicle Screw Systems because a crack may develop in the handle, potentially progressing with continued use.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical device that could lead to instrument failure during use. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
SpineFrontier, Inc. is recalling four units of the Inline Persuader PedFuse Pedicle Screw System, Part Number 11-80164. The recall is due to a potential defect where a crack may develop in the handle of the instrument. If the user continues to use the affected instrument, the crack may progress.
The affected devices are identified by Lot/Serial Numbers 06440-0000, 06441-0000, and AG24. The products were distributed nationwide, including in Texas, Ohio, Virginia, and Washington, DC. The source text does not specify the number of affected patients or report any injuries or illnesses associated with the defect.
Healthcare providers and consumers should stop using the affected Inline Persuader instruments immediately. SpineFrontier, Inc. is the recalling firm responsible for managing the recall. Users should contact the manufacturer for instructions on how to return or replace the devices.
The recalled product
- Product
- lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
- Manufacturer
- SpineFrontier, Inc.
- Hazard
- Affected units
- 4
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 (3)
- Lot/Serial Numbers: 06440-0000
- 06441-0000
- AG24
Distribution
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