# FDA recall Z-1494-2021

> **Coltene Whaledent Inc** · Class II · device recall initiated 2021-03-18.

## Product

Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use 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. Model number/Catalog number: L741

## Reason for recall

The incorrect dental pins were packaged and subsequently distributed.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela.

## Key facts

- **Recall number:** Z-1494-2021
- **Recalling firm:** Coltene Whaledent Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-18
- **Report date:** 2021-05-05

- **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-1494-2021

## Citation

> AI Analytics. FDA recall Z-1494-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1494-2021. Source: US FDA. Licensed CC0.

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