BEUDAMED
    FDA Enforcement Class II Ongoing

    REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R

    Recall: Z-2010-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-2010-2023
    Event ID
    92459
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Limacorporate S.p.A
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 5, 2023
    Initiation Date
    May 30, 2023
    Classification Date
    June 27, 2023
    Address
    Via Nazionale 52, Di San Daniele, San Daniele Del Friuli, N/A, N/A, Italy

    Description

    REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R

    Reason

    Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

    Code Info

    UDI-DI: 08033390244893; All Lots

    Distribution

    US Nationwide distribution in the states of MI, IL, ND, MO, OK.

    Quantity

    13 units