BEUDAMED
    FDA Enforcement Class II Terminated

    UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S

    Recall: Z-2443-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2443-2018
    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

    UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S

    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

    330021S - Lot # F8ML, FEDJ & FF38 330023S - Lot # EF05/G, EGNK/G, F8MM, F9J2, FAPZ, FBE8, FBPB, FCFQ, FCJP, FEDK, FF39 & FFH7 330025S - Lot # FAE6, FBPC, FCFR, FCJQ, FEDL & FFH8 330030S - Lot # EMGF/1, ENHN, EPQM-FBE5, FBPD, FBPE, FBPF, FEDM, FEXQ, FEXR, FFH9 & FGHY 330217S - Lot # F7BY, F7BZ, F7C0-F7C1, F7MV, F98K, F9K7, FAFY, FAQ0, FC2Y, FCJR, FEDN, FEDP, FFHA, FFHB 330220S - Lot # F7C2, F7C3, F7C3/1, F7MW, F8KW, F8WR, F9J1, FAQ1, FBP3, FC2Z, FD69, FEDQ, FEDR, FGNC & FHLM 330225S - Lot # F7N0, F8P5, F8WS-, FAQ2, FBP4, FEDS & FHLN 330230S - Lot # F7MX, F8WT, F9SZ, FAFZ, FBE6, FEDT, FEDT/1 & FEDT/Q 330420S - Lot # F7C4, F7MY, F8WU, F942, F9CK, FA80, FB9L, FBPG, FEDU & FGJD 330425S - Lot # F7MZ, F8P6, F8XQ, F9K8, FB4X, FBPH, FBPJ, FF3A & FFHD 330430S - Lot # F7C5, F9EU, F9SY, FA81, FB9M, FBE7, FBPK, FEDV & FFHE

    Distribution

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