Drug recall
Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental…
FDA recall event 79066 · Class II · Keystone Dental Inc
Key facts
| Event ID | 79066 |
|---|---|
| Recall numbers | Z-0718-2018 |
| Recalling firm | Keystone Dental Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. |
| Initiation date | Jun 16, 2017 |
| Report date | Mar 7, 2018 |
| Termination date | Apr 16, 2019 |
| City | Burlington |
| State | MA |
| Country | United States |
| FEI number | 3005990499 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: