Device recall
Z-0044-2025: MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA device recall · Class II · Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-0044-2025 |
|---|---|
| Recall event | 95277 |
| Product | MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 |
| Product code | OLO |
| Recalling firm | Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K093425 |
| FEI number | 3003070421 |
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