Drug recall
Restoris MCK Onlay Insert Extractor.
FDA recall event 80016 · Class II · Mako Surgical Corporation
Key facts
| Event ID | 80016 |
|---|---|
| Recall numbers | Z-2051-2018 |
| Recalling firm | Mako Surgical Corporation |
| Product type | Devices |
| Products | Restoris MCK Onlay Insert Extractor. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Possible hinge pin disassociation from the Mako Onlay Insert Extractor. |
| Initiation date | Jan 19, 2018 |
| Report date | Jun 13, 2018 |
| Termination date | Sep 16, 2020 |
| City | Davie |
| State | FL |
| Country | United States |
| FEI number | 3005985723 |
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: