BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.

    Recall: Z-2278-2013 · Reported October 2, 2013

    Enforcement

    Recall Number
    Z-2278-2013
    Event ID
    65009
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2013
    Initiation Date
    March 8, 2013
    Classification Date
    September 25, 2013
    Termination Date
    May 21, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.

    Reason

    Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).

    Code Info

    Part Number 241.267, lot number 8037923

    Distribution

    Nationwide Distribution including CA,and VA. .

    Quantity

    2