Drug recall
Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for…
FDA recall event 80552 · Class II · Mako Surgical Corporation
Key facts
| Event ID | 80552 |
|---|---|
| Recall numbers | Z-2794-2018 |
| Recalling firm | Mako Surgical Corporation |
| Product type | Devices |
| Products | Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Out of tolerance. |
| Initiation date | May 10, 2018 |
| Report date | Aug 22, 2018 |
| Termination date | Jan 17, 2021 |
| 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: