BEUDAMED
    FDA Enforcement Class II Terminated

    Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.

    Recall: Z-2004-2016 · Reported July 13, 2016

    Enforcement

    Recall Number
    Z-2004-2016
    Event ID
    74263
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Musculoskeletal Transplant Foundation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2016
    Initiation Date
    April 21, 2016
    Classification Date
    July 7, 2016
    Termination Date
    October 18, 2016
    Address
    125 May St Ste 300, N/A, Edison, NJ, 08837-3264, United States

    Description

    Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.

    Reason

    AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field.

    Code Info

    Serial 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122

    Distribution

    nationwide

    Quantity

    114 units