BEUDAMED
    FDA Enforcement Class II Ongoing

    Integra Universal Flexible Arm part number REF 1362275

    Recall: Z-0906-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0906-2022
    Event ID
    89830
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2022
    Initiation Date
    February 28, 2022
    Classification Date
    April 11, 2022
    Address
    1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States

    Description

    Integra Universal Flexible Arm part number REF 1362275

    Reason

    Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.

    Code Info

    UDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009

    Distribution

    US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TX

    Quantity

    54