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U.S. Department of Health and Human Services

Class 2 Device Recall Bluephase Style Light Pin Point Probe 62 mm

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 Class 2 Device Recall Bluephase Style Light Pin Point Probe 62 mmsee related information
Date Initiated by FirmApril 14, 2014
Date PostedJune 09, 2014
Recall Status1 Terminated 3 on November 05, 2015
Recall NumberZ-1740-2014
Recall Event ID 67998
510(K)NumberK110756 
Product Classification Activator, ultraviolet, for polymerization - Product Code EBZ
Productbluephase 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.
Code Information Reference number 636241, all lots
Recalling Firm/
Manufacturer		 Ivoclar Vivadent, Inc.
175 Pineview Dr
Buffalo NY 14228-2231
For Additional Information Contact
716-691-0010
Manufacturer Reason
for Recall		A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
FDA Determined
Cause 2		Other
Actionlvoclar Vivadent, Inc. sells the affected medical device through Dental Dealer partners (initial consignees) who in turn sell directly to the dentist's office. In this case, lvoclar Vivadent, Inc. handled direct drop shipment of the device to end user dental offices in 80% of the cases. Where lvoclar Vivadent has direct shipment information available, dentist offices will be notified directly. The Dental Dealer partners will be notified of this recall and asked to cooperate and provide name and address listings for all dental office customers where they have shipped the Pin Point probe. The dealer will also be given a customer communication to send directly to the dentists purchasing the device.
Quantity in Commerce241 units
DistributionWorldwide Distribution: US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = EBZ
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