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Recall Observatory FDA recall evidence

Device 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.

Z-1740-2014

April 14, 2014

Class II

Product summary

Firm
Ivoclar Vivadent, Inc.
Event
Event 67998
Status
Terminated
Classification
Class II
Quantity
241 units
Official record key
device-enforcement:Z-1740-2014

Official wording

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

Code information: Reference number 636241, all lots

Distribution pattern: Worldwide Distribution: US Nationwide and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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