BEUDAMED
    FDA Enforcement Class II Terminated

    Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20¿. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.

    Recall: Z-0603-2020 · Reported December 11, 2019

    Enforcement

    Recall Number
    Z-0603-2020
    Event ID
    84230
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Miami Device Solutions, LLC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 11, 2019
    Initiation Date
    January 15, 2019
    Classification Date
    December 5, 2019
    Termination Date
    December 11, 2020
    Address
    7620 Nw 25th St Ste 3, Miami, FL, 33122-1719, United States

    Description

    Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20¿. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.

    Reason

    Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.

    Code Info

    Lot number PM00208

    Distribution

    US Nationwide distribution in the states of FL, RI, MA, PA, NY, OH, GA, WA, AL, CA, TX, VA.

    Quantity

    15 units