BEUDAMED
    FDA Enforcement Class II Terminated

    TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractures. The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.

    Recall: Z-2849-2016 · Reported September 28, 2016

    Enforcement

    Recall Number
    Z-2849-2016
    Event ID
    75080
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trimed Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2016
    Initiation Date
    August 29, 2016
    Classification Date
    September 20, 2016
    Termination Date
    November 1, 2016
    Address
    27533 Avenue Hopkins, Santa Clarita, CA, 91355-3910, United States

    Description

    TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractures. The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.

    Reason

    TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.

    Code Info

    Lot no. 06206

    Distribution

    Worldwide Distribution-US (nationwide) including states of: Alabama, Florida, Indiana, Connecticut, California, Wisconsin, Missouri, Florida, Hawaii; and countries of: Sweden and South Africa.

    Quantity

    30 units