BEUDAMED
    FDA Recall Terminated

    Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU 90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK 90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures

    Recall: Z-1976-2014 · Initiated June 11, 2014

    Recall

    Recall Number
    Z-1976-2014
    Event Number
    68519
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    HPP
    Status
    Terminated
    Root Cause
    Manufacturing material removal
    Initiated
    June 11, 2014
    Posted
    July 2, 2014
    Terminated
    December 19, 2014
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU 90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK 90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures

    Reason

    LED battery chargers may prematurely fail and will not charge the LED battery as intended

    Action

    Integra initiated a voluntary recall on June 11, 2014 to consignees that have been shipped affected product lots of Integra LED Battery Chargers, Catalogue No. 90523. The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. The consignee notification: Advises them of the nature of the issue and the potential for an adverse patient consequence. Advises them to review their inventory and how to determine if they have affected battery chargers. Advises them to immediately stop the use or distribution of any affected product lot numbers they may have. Requests they identify and report to Integra if they do or do not have any unexpired affected product lots. Advises them replacements battery chargers will be shipped for any affected products they affirm are in their possession and how to return their affected product. Questions regarding these instructions, please contact Integra Customer Service at 1-800-431-1123 or your Integra sales

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Arab Emirates, Denmark, Germany, Great Britain, India, Ireland, Israel, Japan, Kuwait, Lebanon, Malta., Netherlands, Panama, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sweden, and Tunisia.

    Quantity

    1250 battery chargers