BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1220-2017 · Initiated January 10, 2017

    Recall

    Recall Number
    Z-1220-2017
    Event Number
    76375
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 10, 2017
    Terminated
    March 26, 2018
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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.

    Action

    Zimmer Biomet initiated a voluntary recall of 1.5mm System due to identification of non-conformance with off-centered slots and the no-go gage starting in the pilot hole. One distributor with affected product outside of Zimmer Biomet control was notified via email and asked to return the affected product. This communication was sent on via e-mail on January 10, 2017. All product has been returned.There were 89 units in Zimmer Biomet control at the time the removal was initiated, however all 100 are now in Zimmer Biomet control. Customer Service Zimmer Biomet, Inc. P.O. Box 708 Warsaw, IN 46581-0708 Phone: 800-348-2759

    Distribution

    Domestic: None VA/DOD: None Foreign: Japan

    Quantity

    11