# FDA recall Z-0376-2019

> **Coltene Whaledent Inc** · Class II · device recall initiated 2018-08-21.

## Product

ParaPost Plus 25  Titanium Alloy  Spiral Vented and   Serrated  Posts   Catalog Number: P2845B    Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation.

## Reason for recall

ParaPost Plus Titanium Posts contain stainless steel post that are a size 4

## Distribution

US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.

## Key facts

- **Recall number:** Z-0376-2019
- **Recalling firm:** Coltene Whaledent Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-21
- **Report date:** 2018-11-14
- **Termination date:** 2020-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cuyahoga Falls, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0376-2019

## Citation

> AI Analytics. FDA recall Z-0376-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0376-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*