BEUDAMED
    FDA Recall Terminated

    Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

    Recall: Z-1310-2021 · Initiated February 24, 2021

    Recall

    Recall Number
    Z-1310-2021
    Event Number
    87481
    Firm
    Arthrex, Inc.
    FEI Number
    1220246
    Product Code
    HTW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 24, 2021
    Terminated
    May 2, 2023
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945

    Description

    Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

    Reason

    The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

    Action

    Consignees were notified via e-mail with URGENT: RECALL NOTIFICATION dated 02/23/2021. The letter identified affected product, reason for recall, and instructed consignee to immediately discontinue use, sale, and distribution of the product as well instructions for handling of affected product.

    Distribution

    US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.

    Quantity

    9 units