BEUDAMED
    FDA Enforcement Class II Terminated

    Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.

    Recall: Z-1113-2017 · Reported February 8, 2017

    Enforcement

    Recall Number
    Z-1113-2017
    Event ID
    76156
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Flower Orthopedics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2017
    Initiation Date
    December 22, 2016
    Classification Date
    January 28, 2017
    Termination Date
    November 27, 2017
    Address
    100 Witmer Rd Ste 280, N/A, Horsham, PA, 19044-2647, United States

    Description

    Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.

    Reason

    The product is being recalled due to incidence and reports of the product breaking during surgery.

    Code Info

    Device Listing: D267957

    Distribution

    Distributed throughout the United States

    Quantity

    N/A