SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusi...
FDA Recall #Z-1565-2014 — Class II — December 23, 2011
Product Description
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
Reason for Recall
It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
Recalling Firm
SpineFrontier, Inc. — Beverly, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
30 devices
Distribution
US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
Code Information
S-Lift Lock Shaft Part number; SI50001 Revisions: A, B Lots: 42613, 2478901R, 42615, 7625701
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated