BEUDAMED
    FDA Enforcement Class II Terminated

    3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.

    Recall: Z-1800-2015 · Reported June 24, 2015

    Enforcement

    Recall Number
    Z-1800-2015
    Event ID
    71276
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2015
    Initiation Date
    May 13, 2015
    Classification Date
    June 15, 2015
    Termination Date
    August 18, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.

    Reason

    Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.

    Code Info

    Part Numbers: 02.240.044, 02.240.244, Lot Numbers 8886011, 8886046

    Distribution

    Nationwide Distribution

    Quantity

    54