Drug recall
Robotic Arm Interactive Orthopedic System (RIO)
FDA recall event 73202 · Class II · Mako Surgical Corporation
Key facts
| Event ID | 73202 |
|---|---|
| Recall numbers | Z-1508-2016 |
| Recalling firm | Mako Surgical Corporation |
| Product type | Devices |
| Products | Robotic Arm Interactive Orthopedic System (RIO) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Revision of the field manual |
| Initiation date | Apr 30, 2014 |
| Report date | Apr 27, 2016 |
| Termination date | Jul 24, 2019 |
| City | Plantation |
| 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: