BEUDAMED
    FDA Recall Open, Classified

    Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.

    Recall: Z-1735-2022 · Initiated August 8, 2022

    Recall

    Recall Number
    Z-1735-2022
    Event Number
    90727
    Firm
    Mako Surgical Corporation
    FEI Number
    3005985723
    Product Code
    OLO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 8, 2022
    Address
    3365 Enterprise Ave, Weston, FL, 33331-3524

    Description

    Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.

    Reason

    Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.

    Action

    Stryker issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated 8/8/2022 on the same date notifying their customers of a correction for the Mako System's USB Converter, Polaris Spectra Camera. The letter provided the issue, potential hazard, potential harm, risk mitigation, and actions needed. The actions included informing users of the medical device correction and forwarding the letter to all individuals who need to be aware within their organization. Complete and sign the enclosed Business Reply Form and email to [email protected] within 5 days. The customer was informed Stryker will replace non-conforming USB Converter, Polaris Cameras, within the scope of the notification with qualified parts unaffected by the nonconformance. If you have any questions, please email:[email protected].

    Distribution

    US Distribution was made to IL and AZ.

    Quantity

    2