BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1565-2014 · Initiated December 23, 2011

    Recall

    Recall Number
    Z-1565-2014
    Event Number
    63145
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 23, 2011
    Posted
    May 7, 2014
    Terminated
    May 20, 2014
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    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

    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

    Action

    Spine Frontier sent an Urgent Notification dated December 23, 2011, consignees. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached acknowledgement form. For questions call 866-914-7717

    Distribution

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

    Quantity

    30 devices