BEUDAMED
    FDA Enforcement Class II Terminated

    XP-CR Tibial Tray - Interlok 71mm Item # 195273

    Recall: Z-2508-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2508-2019
    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 71mm Item # 195273

    Reason

    The locking bar not fully engaging

    Code Info

    Lot Number 663640 262420 571030 590700 590710 676280 917650 320580 966740 995980 996090 966740R 043890 159270 206840 258080 283210 841530 043900 066200 090220 066200R 322070 322070R 383700 352840 283180 359640 322090 429260 374800 403830 159260 456770 041150 579240 899740 274590 274530 274580 041240 041190 503440 585580 993810 666890 503460 888430 221170 985320 374080 374070 279030 599140 576020 943390 821310 411240 450350 600790 712570 717180 717180R 018020 111590 676310 676310R 072520 218650 291200 072520R 672570 289190 562280 148430 291190 351320 445400 445410 486120 445400R 445410R

    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

    454 units