BEUDAMED
    FDA Enforcement Class II Terminated

    Vanguard XP Tibial Tray 67 mm Item # 195247

    Recall: Z-2530-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2530-2019
    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 67 mm Item # 195247

    Reason

    The locking bar not fully engaging

    Code Info

    Lot Number 332640 833160 514940 372960 372970 514920 752020 752030 919210 764330 754460 884550 837740 764340 861170 884360 887950 935780 935800 953910 968990 953950 928850 936190 953930 953940 861160 663120 660390 663080 663110 584200

    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

    Quantity

    74 units