BEUDAMED
    FDA Enforcement Class II Terminated

    bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.

    Recall: Z-1740-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1740-2014
    Event ID
    67998
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ivoclar Vivadent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    April 14, 2014
    Classification Date
    June 9, 2014
    Termination Date
    November 5, 2015
    Address
    175 Pineview Dr, N/A, Buffalo, NY, 14228-2231, United States

    Description

    bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.

    Reason

    A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.

    Code Info

    Reference number 636241, all lots

    Distribution

    Worldwide Distribution: US Nationwide and the country of Canada.

    Quantity

    241 units