BEUDAMED
    FDA Enforcement Class II Ongoing

    Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615

    Recall: Z-0727-2023 · Reported December 28, 2022

    Enforcement

    Recall Number
    Z-0727-2023
    Event ID
    91183
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Corin Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 28, 2022
    Initiation Date
    November 8, 2022
    Classification Date
    December 19, 2022
    Address
    Unit 1-57-8, Corinium Centre, Cirencester, N/A, United Kingdom

    Description

    Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615

    Reason

    The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.

    Code Info

    UDI/DI (01) 0 5055196 96834, Lot 503151

    Distribution

    US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.

    Quantity

    12 units