SpineFrontier, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1565-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 23, 2011

Date Posted: May 14, 2014

Recall Number: Z-1565-2014

Event ID: 63145

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

Status: Terminated

Product Quantity: 30 devices

Code Information:

S-Lift Lock Shaft Part number; SI50001 Revisions: A, B Lots: 42613, 2478901R, 42615, 7625701

Distribution Pattern:

US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO

Voluntary or Mandated:

Voluntary: Firm initiated