Device recall
Z-0472-2021: Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software…
FDA device recall · Class II · Mako Surgical Corporation
Key facts
| Recall number (Z-number) | Z-0472-2021 |
|---|---|
| Recall event | 86700 |
| Product | Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone… |
| Product code | OLO |
| Recalling firm | Mako Surgical Corporation |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K142350 |
| 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