Max Implant System — Class II medical device recall Z-0718-2018
Terminated recall by Keystone Dental Inc, reported 2018-03-07, distributed nationwide. An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
| Recall number | Z-0718-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Dental Inc, Burlington, MA, United States |
| Recall initiated | 2017-06-16 |
| Classified | 2018-02-26 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2019-04-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 72 |
| Reason classes | labeling |
| Lot numbers | 31444 |
| Model numbers | D-TAP-MAX7-7 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0718-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.