# FDA recall Z-2162-2018

> **Keystone Dental Inc** · Class II · device recall initiated 2018-05-01.

## Product

Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K    Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

## Reason for recall

The implants are mislabeled.

## Distribution

US Distribution to the states of :  CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.

## Key facts

- **Recall number:** Z-2162-2018
- **Recalling firm:** Keystone Dental Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-01
- **Report date:** 2018-06-20
- **Termination date:** 2018-09-14

- **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-2162-2018

## Citation

> AI Analytics. FDA recall Z-2162-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2162-2018. Source: US FDA. Licensed CC0.

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