FDA recall Z-3214-2017

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-08-04

Report date

2017-10-04

Termination date

2018-01-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3214-2017