BEUDAMED
    FDA Recall Terminated

    25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.

    Recall: Z-0121-2017 · Initiated August 11, 2016

    Recall

    Recall Number
    Z-0121-2017
    Event Number
    74918
    Firm
    Synergetics Inc
    FEI Number
    1000119053
    Product Code
    HQE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 11, 2016
    Posted
    October 18, 2016
    Terminated
    April 27, 2017
    Address
    3845 Corporate Centre Dr, O Fallon, MO, 63368-8678

    Description

    25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.

    Reason

    Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.

    Action

    A customer notification letter was sent out on 8/11/2016 to the hospital/surgical center level. Customers were asked to fill out and return a recall acknowledgment form and send back any affected devices.

    Distribution

    Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.

    Quantity

    255 units