BEUDAMED
    FDA Enforcement Class II Terminated

    Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.

    Recall: Z-1029-2015 · Reported February 4, 2015

    Enforcement

    Recall Number
    Z-1029-2015
    Event ID
    69963
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthosensor, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2015
    Initiation Date
    December 5, 2014
    Classification Date
    January 29, 2015
    Termination Date
    March 13, 2015
    Address
    1560 Sawgrass Corporate Pkwy, 4th Floor, Sunrise, FL, 33323-2858, United States

    Description

    Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.

    Reason

    Presence of one inoperable (dead) sensor pad.

    Code Info

    Model SYK-TRCR 02, Lot # 091914V11770, Serial #s: 411654008, 411585023, 411654007, 411585032, 411585014, 411654016, 411585017, 411654015, 411585030, 411654020, 411654004, 411654010, 411585007, 411585005, 411654011, 411585036, 411585035, 411654018, 411654012, 411585011, 411654014, 411654005, 411654001, 411585003.

    Distribution

    US Distribution to the states of : IL, MI, NY, CA, VA and NV.

    Quantity

    22 devices