BEUDAMED
    FDA Recall Terminated

    Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF procedure.

    Recall: Z-0657-2019 · Initiated November 26, 2018

    Recall

    Recall Number
    Z-0657-2019
    Event Number
    81645
    Firm
    Howmedica Osteonics Corp.
    FEI Number
    3004024955
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 26, 2018
    Terminated
    May 26, 2020
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF procedure.

    Reason

    Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface. Additionally, upon further investigation, it was observed that some parts exhibited an edge on the intersection between the radius and the diameter of the probe.

    Action

    The firm, Stryker, sent an "Urgent Medical Device Recall" letter dated 11/14/2018 to its customers on 11/26/2018. The letter described product, problem and actions to be taken. The customers were instructed to: Examine your inventory; Immediately quarantine the affected product; and complete customer response form to Stryker Spine at email: [email protected]. For questions contact Manager-Regulatory Compliance & Quality System at 866-45-SPINE (77463)..

    Distribution

    Worldwide distribution: US Distribution to the state of: PA and countries of:: Australia, Canada, France, Italy, Netherlands, Poland, and Spain.

    Quantity

    39