Device recall
Z-2232-2011: MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM…
FDA device recall · Class II · Mako Surgical Corporation
Key facts
| Recall number (Z-number) | Z-2232-2011 |
|---|---|
| Recall event | 58464 |
| Product | MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.*** Manufactured in USA*** MAKO SURGICAL CORP. 2555 Davie Road, Ft… |
| Product code | KQM |
| Recalling firm | Mako Surgical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 9, 2011 |
| FEI number | 3005985723 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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