BEUDAMED
    FDA Enforcement Class II Terminated

    Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.

    Recall: Z-1850-2021 · Reported June 23, 2021

    Enforcement

    Recall Number
    Z-1850-2021
    Event ID
    87959
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Corin Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 23, 2021
    Initiation Date
    May 6, 2021
    Classification Date
    June 11, 2021
    Termination Date
    July 5, 2023
    Address
    Unit 1-57-8, Corinium Centre, Cirencester, N/A, United Kingdom

    Description

    Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.

    Reason

    Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.

    Code Info

    Lot Number 465498

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    4 units