Z-1740-2014Class II

bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe...

Name: Z-1740-2014 bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe...
Creator: Ivoclar Vivadent, Inc.
Published: 2014-04-14
License: https://open.fda.gov/license/

Ivoclar Vivadent, Inc. / initiated 2014-04-14 / Terminated

FDA source

Ivoclar Vivadent, Inc. began a recall of 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... on 2014-04-14. FDA classified it as Class II and gives the reason as "A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1740-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Posted: 2014-06-09
Terminated: 2015-11-05
Recalling firm: Ivoclar Vivadent, Inc.
Product: 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.
Product code: EBZ Activator, Ultraviolet, For Polymerization
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 root cause: Other
Action: lvoclar 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 commerce: 241 units
Distribution: Worldwide Distribution: US Nationwide and the country of Canada.
Product codes and lots: Reference number 636241, all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1740-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1740-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-09

Product code EBZ

K110756Class IIBluephase StyleIvoclar Vivadent, Inc. / cleared 2011-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)