BEUDAMED
    FDA Recall Terminated

    Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.

    Recall: Z-0828-2016 · Initiated December 18, 2015

    Recall

    Recall Number
    Z-0828-2016
    Event Number
    73180
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 18, 2015
    Terminated
    August 1, 2016
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.

    Reason

    Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.

    Action

    Stryker Spine sent Urgent Product Removal notification letters to branches/agencies on 12/18/2015 via FedEx. The letters provided a description of the affected product, the issue, potential hazards and risk mitigations, and actions to be taken. Customers were asked to examine their inventory and hospital locations to identify the product and reconcile with the affected catalog and lot numbers provided. The Customer Response Form and Product Quantity Tracking Spreadsheet for Health Care Facilities should be completed and returned within five days of receipt of the notice to the e-mail or fax number provided. Questions can be directed to Nabil Riaz - Regulatory Compliance Specialist, Regulatory Compliance & Quality Systems at [email protected].

    Distribution

    Nationwide Distribution

    Quantity

    31 units