lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
FDA Recall #Z-0977-2015 — Class II — December 19, 2014
Product Description
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Reason for Recall
A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
Recalling Firm
SpineFrontier, Inc. — Beverly, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4 devices
Distribution
Nationwide Distribution including TX, OH, VA, and Washington, DC.
Code Information
Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated