# FDA recall Z-0718-2018

> **Keystone Dental Inc** · Class II · device recall initiated 2017-06-16.

## Product

Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7      Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.

## Reason for recall

An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.

## Distribution

USA (nationwide) Distribution to the states of :  CA, CO, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and  WV; and Internationally to Canada

## Key facts

- **Recall number:** Z-0718-2018
- **Recalling firm:** Keystone Dental Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-16
- **Report date:** 2018-03-07
- **Termination date:** 2019-04-16

- **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-0718-2018

## Citation

> AI Analytics. FDA recall Z-0718-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0718-2018. Source: US FDA. Licensed CC0.

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