Recall Z-1740-2014 ยท EBZ Activator, Ultraviolet, For Polymerization
Ivoclar Vivadent, Inc.
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.
| Date | Jun 9, 2014 (initiated Apr 14, 2014) |
| Status | Terminated |
| Reason | A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes. |
| 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 d |
| Quantity | 241 units |
| Distribution | Worldwide Distribution: US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110756 | BLUEPHASE STYLE Ivoclar Vivadent, Inc., Aug 29, 2011 |