bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory
FDA device recall Z-1740-2014 · posted 2014-06-09 · Terminated
Recall details
- Recalling firm
- Ivoclar Vivadent, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- EBZ
- Quantity affected
- 241 units
- Distribution
- Worldwide Distribution: US Nationwide and the country of Canada.
- Date initiated
- 2014-04-14
- Date posted
- 2014-06-09
- Date terminated
- 2015-11-05
- Location
- Buffalo, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLUEPHASE STYLE (K110756) | Ivoclar Vivadent, Inc. | 2011-08-29 |