Z-3217-2017 Class II Terminated

Recalled by Ultradent Products, Inc. — South Jordan, UT

Recall Details

Product Type
Devices
Report Date
October 4, 2017
Initiation Date
August 4, 2017
Termination Date
January 4, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
26 units

Product Description

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..

Reason for Recall

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

Distribution Pattern

Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.

Code Information

Lot numbers BDB9Q, BDHWK, BDTBJ, and BDX3F