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.
What this means for you
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
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
- SevereSpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage
FDA (Devices) · 2014-05-14
- ModerateSpineFrontier Recalls Arena-L Trial Handles and Heads Due to Compatibility Issues
FDA (Devices) · 2014-01-22
- ModerateSpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues
FDA (Devices) · 2014-01-22
Same hazard · structural failure
See all →- SevereMondraker Recalls Mountain Bicycles with ONOFF S9 Carbon Handlebars
CPSC · 2026-09-03
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- High