BEUDAMED
    FDA Enforcement Class II Terminated

    Vanguard XP Tibial Tray 71 mm Item # 195249

    Recall: Z-2532-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2532-2019
    Event ID
    83594
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2019
    Initiation Date
    August 15, 2019
    Classification Date
    September 12, 2019
    Termination Date
    April 16, 2021
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Vanguard XP Tibial Tray 71 mm Item # 195249

    Reason

    The locking bar not fully engaging

    Code Info

    Lot Number 584220 590500 590510 663160 663180 663170 660420 117730 332670 833200 373020 373040 373030 515030 515020 515040 752090 752070 752080 919240 919230 846510 764370 764380 837780 754480 837770 861200 881500 881510 984430 984400 039230 052240 039240 881530 984390 039220 984420 052260 984410 090340 570960

    Distribution

    State NY IN OH MI GA SC FL MO WI MN ND SD NE NJ PA MD IL IA CA VA NC DC WV AR AL MS AL MI WA OR ID LA FL KS TN MA KY OK TX TX CT AZ NV NM MT WY CO UT DC WY Country: KOREA CHINA CANADA AUSTRALIA JAPAN EMEA SWEDEN ITALY