# FDA recall Z-3218-2017

> **Ultradent Products, Inc.** · Class II · device recall initiated 2017-08-04.

## Product

Ultradent Products, Inc.  Paper Points, Size 50 PN #1559, 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

- **Recall number:** Z-3218-2017
- **Recalling firm:** Ultradent Products, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3218-2017

## Citation

> AI Analytics. FDA recall Z-3218-2017. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-3218-2017. Source: US FDA. Licensed CC0.

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