BEUDAMED
    FDA Enforcement Class II Terminated

    Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.

    Recall: Z-1206-2019 · Reported May 1, 2019

    Enforcement

    Recall Number
    Z-1206-2019
    Event ID
    82009
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arthrex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 1, 2019
    Initiation Date
    January 14, 2019
    Classification Date
    April 23, 2019
    Termination Date
    August 31, 2023
    Address
    1370 Creekside Blvd, N/A, Naples, FL, 34108-1945, United States

    Description

    Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.

    Reason

    Devices may generate excessive heat during use.

    Code Info

    Lot Numbers: 10211276 (expiration date: 4/30/2023 and 10202784 (expiration date: 3/31/2023

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, NC, ND, NH, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and to countries of: Germany, Brazil and Australia.

    Quantity

    2324