BEUDAMED
    FDA Enforcement Class II Terminated

    XP-CR Tibial Tray - Interlok 75mm Item # 195275

    Recall: Z-2510-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2510-2019
    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 75mm Item # 195275

    Reason

    The locking bar not fully engaging

    Code Info

    Lot Number 663790 262440 513090 590770 590780 590790 663740 663770 917760 206860 938190 966780 206860R 043930 066230 090240 851340 322130 258100 283250 434280 434280R 429280 456780 513110 434270 996020 374820 469540 041250 666900 041160 579270 503470 503450 503410 576030 279050 599160 672640 374100 821350 821350R 450370 600810 712590 717200 600810R 717200R 148450 199750 676260 676330 676290 562300 562300R 279260 308120 308130 473000 502860 553890 571050 279260R 308120R 473000R

    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

    369 units