BEUDAMED
    FDA Enforcement Class II Terminated

    DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty

    Recall: Z-0992-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0992-2018
    Event ID
    79242
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    June 30, 2017
    Classification Date
    March 13, 2018
    Termination Date
    April 13, 2018
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty

    Reason

    Product may contain the presence of melted sterile packaging upon opening.

    Code Info

    part number: 650-1162 lot number: 2016030466

    Distribution

    US in the state of Texas

    Quantity

    30