BEUDAMED
    FDA Enforcement Class II Terminated

    Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

    Recall: Z-1094-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1094-2015
    Event ID
    70055
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 18, 2015
    Initiation Date
    January 6, 2012
    Classification Date
    February 11, 2015
    Termination Date
    March 30, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

    Reason

    Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B), which corrected an error in the indication statement.

    Code Info

    Part 10847A

    Distribution

    Distributed in the state of WI

    Quantity

    38