Device product
Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
Z-3217-2017
Product summary
- Event
- Event 77891
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-3217-2017
Official wording
Reason: The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Code information: Lot numbers BDB9Q, BDHWK, BDTBJ, and BDX3F
Distribution pattern: Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
Derived failure modes
-
Unknown
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.