BEUDAMED
    FDA Enforcement Class II Terminated

    Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612

    Recall: Z-3176-2018 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-3176-2018
    Event ID
    80843
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2018
    Initiation Date
    July 20, 2018
    Classification Date
    September 14, 2018
    Termination Date
    June 4, 2020
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612

    Reason

    The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.

    Code Info

    Lot Number 611330, UDI (1)00880304008526(17)221010(10)611330

    Distribution

    The products were distributed to the following US states: IN, TN. The products were distributed to the following foreign countries: Australia, Chile, Netherlands.

    Quantity

    52