BEUDAMED
    FDA Recall 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 · Initiated August 21, 2015

    Recall

    Recall Number
    Z-0025-2016
    Event Number
    72068
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 21, 2015
    Posted
    October 6, 2015
    Terminated
    October 13, 2016
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    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.

    Action

    Integra sent an Urgent-Voluntary Medical Device Recall letter dated August 19, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm instructed their customers to: 1. Review your inventory and determine if you have an UCHRAP Adapter Plate with an affected serial number listed on the next page. If you do not, it is not affected and you can continue to use it. 2. If you do have product with a serial number listed on the next page, stop using it immediately and remove it from service. 3. Complete the attached form. If you do not have product with a serial number listed, check the box, I do not have any product with a serial number on the list below. 4. If you do have product with a serial number listed, check the box, I do have product(s) with a serial number below. Circle the lot numbers and record the total quantity of all lot numbers you have. 5. Complete the other information and return it by email or fax as indicated on the form or by providing it to your Integra Neuro Specialist. If an Integra Neuro Specialist has not already done so, Customer Service will contact you and provide an RMA number and directions for returning and replacing the product. Should you have any questions regarding these instructions, please call : (513) 533-7932. For any other questions, please call (609) 936-6822.

    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