BEUDAMED
    FDA Enforcement Class II Terminated

    Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions

    Recall: Z-2791-2016 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2791-2016
    Event ID
    74727
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 21, 2016
    Initiation Date
    June 30, 2016
    Classification Date
    September 13, 2016
    Termination Date
    June 21, 2017
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions

    Reason

    Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.

    Code Info

    Catalog number 18220930S and Lot Code K836729

    Distribution

    US distribution to state of: CA.

    Quantity

    1 unit in total