Drug recall
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm…
FDA recall event 67444 · Class II · Mako Surgical Corporation
Key facts
| Event ID | 67444 |
|---|---|
| Recall numbers | Z-1132-2014 |
| Recalling firm | Mako Surgical Corporation |
| Product type | Devices |
| Products | Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product may be mislabeled and could result in the incorrect implant being used. |
| Initiation date | Jan 9, 2014 |
| Report date | Mar 12, 2014 |
| Termination date | Aug 14, 2014 |
| 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: