Device recall
Z-0915-2009: Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002…
FDA device recall · Class II · Mako Surgical Corporation
Key facts
| Recall number (Z-number) | Z-0915-2009 |
|---|---|
| Recall event | 48598 |
| Product | Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002. Manufactured by: MAKO Surgical, Corp. The devices are accessories used with MAKO's Tactile Guidance System (TGS). The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial… |
| Product code | HAW |
| Recalling firm | Mako Surgical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2009 |
| 510(k) numbers | K072806 |
| 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