FDA Device

Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 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.

Hazard

The barcode label was placed underneath the sterile barrier and the product was re-wrapped.

What You Should Do

Remedy

The recalling firm issued letters dated August 4, 2017 via certified mail,2-day delivery mail, or email on August 4, 2017. The letter identified the affected product, problem, and actions to be taken. For questions contact Regulatory Affairs Specialist at Ultradent Products, Inc.

Products

Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturat
Brand
Ultradent Products, Inc.
UPC
Lot numbers BCDZQ, BCPRC, and BD3MT

Units Affected

61 units