BEUDAMED
    FDA Enforcement Class II Terminated

    ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S

    Recall: Z-2444-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2444-2018
    Event ID
    80312
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NewDeal SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    May 22, 2018
    Classification Date
    July 16, 2018
    Termination Date
    November 4, 2019
    Address
    Immeuble Sequoia 2 97 A, 97 Allee Alexandre Borodineimmeuble Sequoia 2 97 Allee Alexandre Borodine, St Priest, N/A, France

    Description

    ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S

    Reason

    Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

    Code Info

    181011S - Lot # E8PF/G, F5CE 181012S - Lot # E8MB/G, E8MV/G & E8PG/G1 181013S - Lot # E8MC/G, E8MW/G, E8NF/G, E8NF/G1, E8NZ/G, E8PH/G, F538, F5CG & F7G7 181014S - Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1 181001S - Lot # E8PB/G & F5CA 181002S - Lot # E8M7/G, E8MR/G & E8PC/G 181003S - Lot # E8MS/G, E8NB/G, E8NV/G, F537 & F5CC 181004S - Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1

    Distribution

    CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI