BEUDAMED
    FDA Enforcement Class II Terminated

    ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9

    Recall: Z-0552-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0552-2018
    Event ID
    78444
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    3M Company - Health Care Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2018
    Initiation Date
    November 1, 2017
    Classification Date
    February 7, 2018
    Termination Date
    July 22, 2020
    Address
    3m Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, 55144-0001, United States

    Description

    ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9

    Reason

    Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.

    Code Info

    (a) Cat #901014, Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2 (b) Cat #901015, Lot Number 7223U2

    Distribution

    AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NH, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI, WV

    Quantity

    996 units