Drug recall
Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in…
FDA recall event 80112 · Class II · Keystone Dental Inc
Key facts
| Event ID | 80112 |
|---|---|
| Recall numbers | Z-2162-2018 |
| Recalling firm | Keystone Dental Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The implants are mislabeled. |
| Initiation date | May 1, 2018 |
| Report date | Jun 20, 2018 |
| Termination date | Sep 14, 2018 |
| 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: