Device recall
Z-1132-2014: Restoris Multicompartmental Knee (MCK) System is an implant system designed to…
FDA device recall · Class II · Mako Surgical Corporation
Key facts
| Recall number (Z-number) | Z-1132-2014 |
|---|---|
| Recall event | 67444 |
| Product | 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 (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is… |
| Product code | NPJ |
| Recalling firm | Mako Surgical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 14, 2014 |
| 510(k) numbers | K090763 |
| FEI number | 3005985723 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database