SpineFrontier, Inc. lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Brand
SpineFrontier, Inc.
Lot Codes / Batch Numbers
Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
Products Sold
Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
SpineFrontier, Inc. is recalling lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 due to A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 12, 2026