Ultradent Products, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3214-2017)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2017.
Data Source: FDA.
Product Description:
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.
Product Classification:
Class II
Date Initiated: August 4, 2017
Date Posted: October 4, 2017
Recall Number: Z-3214-2017
Event ID: 77891
Reason for Recall:
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Status: Terminated
Product Quantity: 61 units
Code Information:
Lot numbers BCDZQ, BCPRC, and BD3MT
Distribution Pattern:
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
Voluntary or Mandated:
Voluntary: Firm initiated