BEUDAMED
    FDA Enforcement Class II Terminated

    ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7

    Recall: Z-0946-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0946-2018
    Event ID
    79051
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    3M Company - Health Care Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    January 31, 2018
    Classification Date
    March 9, 2018
    Termination Date
    February 11, 2021
    Address
    3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul, MN, 55144-0001, United States

    Description

    ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7

    Reason

    3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement.

    Code Info

    All lots

    Distribution

    US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates

    Quantity

    162,348 units