BEUDAMED
    FDA Enforcement Class II Ongoing

    Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A

    Recall: Z-2688-2024 · Reported August 28, 2024

    Enforcement

    Recall Number
    Z-2688-2024
    Event ID
    95066
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intrinsic Therapeutics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2024
    Initiation Date
    July 25, 2024
    Classification Date
    August 20, 2024
    Address
    30 Commerce Way, Woburn, MA, 01801-8503, United States

    Description

    Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A

    Reason

    At least two units have been found to be missing a weld.

    Code Info

    REF: BAR-IMPACTOR, P/N: 400906-A; UDI-DI: M906IMP1A0; Lot numbers: 10282203, 06152307, 08292301, 10112307.

    Distribution

    US Nationwide distribution.

    Quantity

    207 units