BEUDAMED
    FDA Enforcement Class II Terminated

    Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.

    Recall: Z-0025-2016 · Reported October 14, 2015

    Enforcement

    Recall Number
    Z-0025-2016
    Event ID
    72068
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2015
    Initiation Date
    August 21, 2015
    Classification Date
    October 6, 2015
    Termination Date
    October 13, 2016
    Address
    311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States

    Description

    Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.

    Reason

    Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing.

    Code Info

    Cat. No. UCHRAP; Serial No.s 900, 901, 902, 904, 905, 906

    Distribution

    Worldwide Distribution - US Distribution to the states of : NJ, TX and WY., and to the countries of : Algeria, Germany and India.

    Quantity

    6 units