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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description "bluephase style Light probe Pin-point 6>2 mm black***REF # 636 241". Ultraviolet activator for polymerization for use during dental curing.
Recall Number Z-1740-2014
Classification Class II
Code Info Reference number 636241, all lots
Product Distributed Qty 241 units
Reason For Recall Subject of this recall is an accessory to a dental curing light called Bluephase Style. The accessory is a pin point light probe. A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.

Event Detail

Event Id 67998
Product Type Devices
Status Ongoing
Recalling Firm Ivoclar Vivadent, Inc.
City Buffalo
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution: US Nationwide and the country of Canada.