BEUDAMED
    FDA Enforcement Class II Terminated

    ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem

    Recall: Z-2821-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2821-2018
    Event ID
    80534
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 22, 2018
    Initiation Date
    June 8, 2018
    Classification Date
    August 14, 2018
    Termination Date
    April 14, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem

    Reason

    Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

    Code Info

    lot 944680. UDI (01)00880304463370(17)280206(10)944680

    Distribution

    US distribution to CA, GA, IL, MO, NY, and VA.

    Quantity

    12