BEUDAMED
    FDA Enforcement Class II Terminated

    ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU

    Recall: Z-0650-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0650-2017
    Event ID
    75540
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Depuy Orthopaedics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 30, 2016
    Initiation Date
    October 25, 2016
    Classification Date
    November 21, 2016
    Termination Date
    June 6, 2017
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU

    Reason

    DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.

    Code Info

    Product Codes: 201001210, ACTIS FLEX REAMER SZ 0/1, GTIN: 10603295434818; 201001220, ACTIS FLEX REAMER SZ 2/3, GTIN: 10603295434870; 201001230, ACTIS FLEX REAMER SZ 4/5, GTIN: 10603295434849; 201001240, ACTIS FLEX REAMER SZ 6/7, GTIN: 10603295434856; 201001250, ACTIS FLEX REAMER SZ 8/9, GTIN: 10603295434863; 201001260, ACTIS FLEX REAMER SZ 10/11, GTIN: 10603295434825; 201001270, ACTIS FLEX REAMER SZ 12, GTIN: 10603295434832

    Distribution

    US Distribution to the states of: CA, KY, LA, MD, ME, NC, NH, NY, TX, VA, WA Foreign: Austria, Ireland, and Japan VA/DOD:

    Quantity

    137