BEUDAMED
    FDA Enforcement Class II Terminated

    Vanguard XP Tibial Tray 75 mm Item # 195251

    Recall: Z-2534-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2534-2019
    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 75 mm Item # 195251

    Reason

    The locking bar not fully engaging

    Code Info

    Lot Number 833220 919250 919260 936260 764410 764420 837800 936240 846540 861190 928760 936250 954020 846530 928770 953990 928800 954000 928790 590580 571000 663280 590570 663250 663260 663270 590590 663240 663300 590560 332710 515110 373070 373080 515090 752140 752130 332740 754500

    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

    110 units