# FDA recall Z-1485-2018

> **Keystone Dental Inc** · Class II · device recall initiated 2018-03-13.

## Product

Genesis Surgical Cassette Tapered      Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket

## Reason for recall

The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs  wobble  within the grommets in the surgical cassette.

## Distribution

USA (nationwide) Distribution and Internationally to Turkey.

## Key facts

- **Recall number:** Z-1485-2018
- **Recalling firm:** Keystone Dental Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-13
- **Report date:** 2018-05-02
- **Termination date:** 2018-07-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burlington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1485-2018

## Citation

> AI Analytics. FDA recall Z-1485-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1485-2018. Source: US FDA. Licensed CC0.

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