FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1740-2014
- 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.
- Status
- Terminated
- Initiated
- 2014-04-14
- Posted
- 2014-06-09
- Terminated
- 2015-11-05
- 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 dealer will also be given a customer communication to send directly to the dentists purchasing the device.
- Quantity
- 241 units
- Distribution
- Worldwide Distribution: US Nationwide and the country of Canada.
- Lot, serial or model codes
- Reference number 636241, all lots
- 510(k) numbers
- ["K110756"]
- PMA numbers
- not on file
- Product code
- EBZ
- Firm FEI
- 1316092
- Firm city
- Buffalo
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28