BEUDAMED
    FDA Enforcement Class II Terminated

    SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

    Recall: Z-0149-2013 · Reported October 31, 2012

    Enforcement

    Recall Number
    Z-0149-2013
    Event ID
    63121
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2012
    Initiation Date
    September 6, 2012
    Classification Date
    October 25, 2012
    Termination Date
    June 3, 2015
    Address
    325 Paramount Drive, N/A, Raynham, MA, 02767-5199, United States

    Description

    SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

    Reason

    Fracture of SPIRALOK Anchors post op, requiring patient revision

    Code Info

    All lot codes

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of AE, AR, AT, AU, BE, BR, CA,, CH,CL .CN, CO, CZ,DE, DK, EC, ES, FI, FR GB, GP, GR, IE, IL, IN, IT, KR, LU, LY, MX, NC NL, NO, NZ, PE, PL PT, RE, RU, SG, SI, TH, TN, TR, UG ,UY , VE, and ZA.

    Quantity

    0