FDA Device recall Z-0718-2018
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…
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of 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… by Keystone Dental, citing an 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0718-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-16 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Keystone Dental |
| Distribution | US |
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
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
Identifiers
| code_info | Catalog Number D-TAP-MAX7-7, Lot 31444 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0718-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.