BEUDAMED
    FDA Enforcement Class II Terminated

    Connecting Bolt, Model 14-442093

    Recall: Z-2875-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2875-2018
    Event ID
    80543
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    June 18, 2018
    Classification Date
    August 17, 2018
    Termination Date
    March 26, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Connecting Bolt, Model 14-442093

    Reason

    Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture.

    Code Info

    ...

    Distribution

    AR, AZ, CA, FL, GA, IN, KY, LA, MA, MI, MN, MO, MT, NJ, NY, OH, SC, TX, UT & WI

    Quantity

    247 units