BEUDAMED
    FDA Enforcement Class II Terminated

    XP-CR Tibial Tray - Interlok 63mm Item # 195269

    Recall: Z-2504-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2504-2019
    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

    XP-CR Tibial Tray - Interlok 63mm Item # 195269

    Reason

    The locking bar not fully engaging

    Code Info

    Lot Number 663420 993820 660430 660430R 262380 395340 445350 584240 562230 578990 579070 043840 159200 917670 996050 043840R 917670R 206800 090150 159210 352790 995940 352780 469480 321920 663450 258040 352770 966700 434250 434260 456730 274630 374760 672430 899750 041270 899710 041200 666860 278990 600750 712530 600750R 821250 821250R 450310 599050 599050R 199780 717140 943340 017920 076390 220020 220020R 175270 228580 175270R 199790 199790R 395350

    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

    322 unit