BEUDAMED
    FDA Recall Terminated

    Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges.

    Recall: Z-1086-2014 · Initiated December 18, 2013

    Recall

    Recall Number
    Z-1086-2014
    Event Number
    67388
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 18, 2013
    Posted
    February 25, 2014
    Terminated
    August 25, 2014
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges.

    Reason

    Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.

    Action

    Stryker sent Urgent Medical Device Removal Notification letter and to their customers via email on 12/18/2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory, return affected product using enclosed pre-paid mailing label, complete Customer Response Form and fax to Regulatory Compliance at 855-632-9049 or mail it to [email protected]. For questions call 201-760-8287, 201-760-8298 or 201-760-8041.

    Distribution

    US Nationwide Distribution

    Quantity

    21 units