BEUDAMED
    FDA Enforcement Class II 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 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2627-2014
    Event ID
    68908
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    September 17, 2014
    Initiation Date
    July 7, 2014
    Classification Date
    September 11, 2014
    Termination Date
    May 8, 2017
    Address
    2 Pearl Ct, N/A, Allendale, NJ, 07401-1611, United States

    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.

    Code Info

    Catalog #IS3021ARI, Lot #'s 20774, 20798, 20805 and 21990

    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