BEUDAMED
    FDA Enforcement Class II Terminated

    Go-EZ Screw 6.5x115, Item Number 19671 - 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-2253-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2253-2019
    Event ID
    83288
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioPro, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 21, 2019
    Initiation Date
    June 25, 2019
    Classification Date
    August 12, 2019
    Termination Date
    May 7, 2020
    Address
    2929 Lapeer Rd, N/A, Port Huron, MI, 48060-2558, United States

    Description

    Go-EZ Screw 6.5x115, Item Number 19671 - 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

    Code Info

    UDI - M209196710 Lot Number - 123118 MFG Date - 4/25/2019

    Distribution

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

    Quantity

    2 units