BEUDAMED
    FDA Enforcement Class II Terminated

    VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H

    Recall: Z-2594-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2594-2017
    Event ID
    77141
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 21, 2017
    Initiation Date
    April 28, 2017
    Classification Date
    June 15, 2017
    Termination Date
    May 15, 2019
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H

    Reason

    Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.

    Code Info

    510K:K150818,K954555 Item Numbers: 00119313016 00119313018 00119313020 00119313516 00119313518 00119313520 00119314016 00119314018 00119314020 00119314516 00119314518 00119314520 00119315016 00119315018 00119315020 Lot Numbers: 60528430 60528430R 367587 368766 368965 369002 368935 61067765 61067765R 61020321 61020321R 369009 61086830 61140159 61151192 61163286 61163286R 61151212 61246966 61244915 61314528 61314528R 61309346 61326723 61326723R 369454 61309347 61309347R 369477 369477R 61352928 61352928R 369558 369837 369823 61625238 61776782 37107690 45003072 37213895 37214379 62388915 62311351 62511283 62547278 62430175 62547305 62461668 62388917 62445943 62430159 62547286 37109076 37109075 37109077 62931598 62950756 62993953 62934787 63004526 63028872 62970952 62993347 62779484 63010741 62986294 62993353 63197443

    Distribution

    Domestic: Puerto Rico, AK AL AR AZ CA CO CT FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Foreign: CANADA, ALGERIA ARGENTINA AUSTRALIA BELGIUM BRAZIL BRIDGEND WALES CHINA DUBAI UAE EGYPT EL SALVADOR ENGLAND ESCHBACH GERMANY EXPORT DORAL FL FRANCE GERMANY GUATEMALA HONDURAS INDIA ITALY JAMAICA JAPAN JORDAN KOREA LEBANON DELIVERY SERVICE (LYNBROOK NY) MALAYSIA MEXICO MIAMI FL MOROCCO NETHERLANDS NEW ZEALAND NICARAGUA PANAMA PERU PHARR TEXAS POLAND PUERTO RICO RIO DE JANEIRO SAUDI ARABIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND THE NETHERLANDS TRIPOLI UK VIRGIN ISLANDS VA/DOD: Both see addresses below

    Quantity

    510