BEUDAMED
    FDA Recall Terminated

    Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter 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, ergonomically shaped anterior edges, and flat posterior edges. This device does not sustain or support life.

    Recall: Z-2627-2014 · Initiated July 7, 2014

    Recall

    Recall Number
    Z-2627-2014
    Event Number
    68908
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 7, 2014
    Posted
    September 11, 2014
    Terminated
    May 8, 2017
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter 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, ergonomically shaped anterior edges, and flat posterior edges. This device does not sustain or support life.

    Reason

    Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.

    Action

    Stryker Spine sent an "Urgent Medical Device Removal Notification/Customer Response" form dated July 7, 2014 to all their affected customers via Fedex. Customers were instructed to examine their inventory and hospital locations to identify the product. Fax a copy of the Customer Response Form to 855-632-9049 or email it to [email protected]. For questions regarding this recall call 201-760-8298.

    Distribution

    Worldwide Distribution - USA including OR, AZ, TN, MA, MD, GA, FL, NY, IA, IN, TX, MI, PA, UT, CA, MN, MO, OH, KS, OK, MT, FL, AL, CO, TN, and WI and Internationally to Australia.

    Quantity

    57 units