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Recall Observatory FDA recall evidence

Device product

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.

Z-1565-2014

December 23, 2011

Class II

Product summary

Firm
SpineFrontier, Inc.
Event
Event 63145
Status
Terminated
Classification
Class II
Quantity
30 devices
Official record key
device-enforcement:Z-1565-2014

Official wording

Reason: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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