BEUDAMED
    FDA Recall Open, Classified

    Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.

    Recall: Z-0295-2019 · Initiated August 27, 2018

    Recall

    Recall Number
    Z-0295-2019
    Event Number
    81106
    Firm
    Arthrex, Inc.
    FEI Number
    1220246
    Product Code
    HAB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 27, 2018
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945

    Description

    Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.

    Reason

    The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.

    Action

    Arthrex notified customers on or about 08/27/2018 via recall letter entitled "URGENT: VOLUNTARY PRODUCT RECALL NOTIFICATION." The recall letter instructed customers to immediately discontinue use, sale and distribution of the affected product and contact Arthrex Product Surveillance at 866-267-9138 or [email protected] as soon as possible to arrange for return of affected product.

    Distribution

    Worldwide - Nationwide Distribution in the states of AL, CA, CO, FL, ID, IL, MA, MD, MI, MO, NC, NE, NY, PA, SC, TN, TX, UT, WI. and the countries of Austria, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Italy, Kuwait, Lithuania, Netherlands, Norway, Poland, Russia, Slovakia, Spain and Switzerland.

    Quantity

    335 devices