BEUDAMED
    FDA Enforcement Class II Terminated

    AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

    Recall: Z-0092-2019 · Reported October 17, 2018

    Enforcement

    Recall Number
    Z-0092-2019
    Event ID
    80971
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2018
    Initiation Date
    August 13, 2018
    Classification Date
    October 9, 2018
    Termination Date
    May 23, 2019
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611, United States

    Description

    AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

    Reason

    The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.

    Code Info

    Lot Number 7HX

    Distribution

    US Nationwide in the states: CA, FL, GA, MI, MN, NJ, NM, and OR

    Quantity

    5