BEUDAMED
    FDA Recall Terminated

    Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    Recall: Z-2254-2019 · Initiated June 25, 2019

    Recall

    Recall Number
    Z-2254-2019
    Event Number
    83288
    Firm
    BioPro, Inc.
    FEI Number
    1832656
    Product Code
    NBH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 25, 2019
    Terminated
    May 7, 2020
    Address
    2929 Lapeer Rd, Port Huron, MI, 48060-2558

    Description

    Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    Reason

    Manufacturing flaw in the sterile barrier system

    Action

    On 6/25/2019, BioPro contacted all customers via telephone. BioPro subsequently emailed all customers a list of impacted products to include details of how products should be returned and actions to be taken. Customers were advised to take the following action: 1) Identify and segregate impacted product. 2) BioPro will send a return shipping label to facilitate a smooth return of product. Reference RMA # when product is returned. Customers with questions may call 1-800-252-7707.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.

    Quantity

    3 units