BEUDAMED
    FDA Recall Terminated

    BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.

    Recall: Z-1664-2013 · Initiated May 17, 2013

    Recall

    Recall Number
    Z-1664-2013
    Event Number
    65432
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    FSM
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 17, 2013
    Posted
    July 5, 2013
    Terminated
    May 17, 2016
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    Description

    BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.

    Reason

    The S-LIFT Instrument Case contained a bracket with peeling nylon coating.

    Action

    Spine Frontier sent an Urgent Advisory Notice letter dated On June 7, 2013 to all consignees via email. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a modification has been implemented for the improved durability of S-LIFT Case Brackets and that SpineFrontier has initiated removal of these cases from the field. An acknowledgement form is to be signed and returned from each recipient of the Advisory Notice. Upon receipt of the acknowledgement form and RMA request for part return, replacement parts will be shipped. For questions call 978-232-3990.

    Distribution

    USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.

    Quantity

    12