Device recall
Z-0385-2013: The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to…
FDA device recall · Class II · Mako Surgical Corporation
Key facts
| Recall number (Z-number) | Z-0385-2013 |
|---|---|
| Recall event | 63607 |
| Product | The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip… |
| Product code | OLO |
| Recalling firm | Mako Surgical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 22, 2013 |
| 510(k) numbers | K081867 |
| FEI number | 3005985723 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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