BEUDAMED
    FDA Enforcement Class II Terminated

    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

    Recall: Z-0533-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0533-2020
    Event ID
    83783
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2019
    Initiation Date
    August 21, 2019
    Classification Date
    November 22, 2019
    Termination Date
    July 21, 2021
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

    Reason

    Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

    Code Info

    LOTS 584440 823130 966710 653720 191230 361690 917170 993450 009590 971720 197730 421300 970590 799740 713840 265680 924350 729030 843020 729020 034400 279060 958550 451520 040360 364420 399470 417590 446550 449550 489790 572090 587200 609410 616720 965280 975560 996130 873200 287000 951480 031170 659320 830600 297280 407350 907020 751730 641070 713850 729050 729040 960150 957220 451540 299920 564400 150450 770600 364540 146250 761320 957590 868620 537430 810590 364560 UDI (01)00887868226441(17)270911(10)823130 (01)00880304804180(17)251120(10)966710 (01)00880304860001(17)270228(10)191230 (01)00880304443044(17)230220(10)265680 (01)00880304443044(17)230315(10)729030 (01)00880304443044(17)230319(10)843020 (01)00880304443044(17)230328(10)729020 (01)00880304443044(17)230430(10)034400 (01)00880304443044(17)230520(10)279060 (01)00880304443044(17)230816(10)958550 (01)00880304443044(17)240212(10)451520 (01)00880304434127(17)230319(10)729050 (01)00880304434127(17)230328(10)729040 (01)00880304434127(17)230408(10)960150 (01)00880304434127(17)230816(10)957220 (01)00880304434127(17)240221(10)451540 (01)00880304434127(17)240714(10)299920 (01)00880304434127(17)250319(10)564400 (01)00880304434127(17)250331(10)150450 (01)00880304434127(17)260118(10)770600 (01)00880304433496(17)230816(10)957590 (01)00880304433496(17)240327(10)868620 (01)00880304433496(17)240521(10)537430 (01)00880304433496(17)240612(10)810590

    Distribution

    US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.

    Quantity

    214741