BEUDAMED
    FDA Recall Terminated

    S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.

    Recall: Z-0274-2014 · Initiated August 28, 2013

    Recall

    Recall Number
    Z-0274-2014
    Event Number
    65760
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 28, 2013
    Posted
    November 14, 2013
    Terminated
    September 13, 2018
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    Description

    S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.

    Reason

    Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.

    Action

    SpineFrontier sent an Urgent Voluntary Recall letter dated August 28, 2013, to all affected customers. The letter identified teh product, the problem, and the action to be taken by the customer. Customers were asked to initiate the immediate return of the parts noted and complete an acknowledgement form and return it to SpineFrontier via fax or email. Customers with questions were instructed to call 978-232-3990. For questions regarding this recall call 978-232-3990.

    Distribution

    Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT

    Quantity

    67