Recall Z-1740-2014— Ivoclar Vivadent, Inc.

Name: FDA recall Z-1740-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-14

Class II · Terminated

Class II FDA medical device recall by Ivoclar Vivadent, Inc., initiated 2014-04-14, terminated 2015-11-05. It names one FDA 510(k) clearance: K110756. 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.. Reason: A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes..

Recalling firm: Ivoclar Vivadent, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Terminated: 2015-11-05
Firm location: Buffalo, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K110756 — BLUEPHASE STYLEIvoclar Vivadent, Inc.·cleared 2011-08-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.