BEUDAMED
    FDA Enforcement Class II Terminated

    various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.

    Recall: Z-1858-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1858-2017
    Event ID
    76507
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2017
    Initiation Date
    February 17, 2017
    Classification Date
    April 18, 2017
    Termination Date
    January 29, 2018
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.

    Reason

    Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

    Code Info

    Item 163005 Lot 309030

    Distribution

    Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK

    Quantity

    28,253 in total