BEUDAMED
    FDA Enforcement Class II Terminated

    1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw

    Recall: Z-1220-2017 · Reported February 22, 2017

    Enforcement

    Recall Number
    Z-1220-2017
    Event ID
    76375
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 22, 2017
    Initiation Date
    January 10, 2017
    Classification Date
    February 16, 2017
    Termination Date
    March 26, 2018
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw

    Reason

    The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.

    Code Info

    95-6104- Item No. 530430- Lot 1.5x4mm HT SD X-DR Screw

    Distribution

    Domestic: None VA/DOD: None Foreign: Japan

    Quantity

    11