BEUDAMED
    FDA Recall Terminated

    S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.

    Recall: Z-0417-2013 · Initiated August 22, 2012

    Recall

    Recall Number
    Z-0417-2013
    Event Number
    63075
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    August 22, 2012
    Posted
    November 21, 2012
    Terminated
    June 11, 2015
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    Description

    S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.

    Reason

    When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides

    Action

    Spine Frontier issued a Correction Notice Letter August 22, 2012 to all affected customers to update the Instructions for Use. The letter identified the affected product, problem and actions to be taken. Customers were Instructed to remove the Instructions for Use they currently have and replace them with the update. The letter instructs customers to complete and return the Response Form to 978-232-3990.

    Distribution

    US Nationwide including the states of: MA and TX.

    Quantity

    19 units