Device recall
Z-2716-2026: TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia…
FDA device recall · Class II · Think Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-2716-2026 |
|---|---|
| Recall event | 99219 |
| Product | TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing… |
| Product code | OLO |
| Recalling firm | Think Surgical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K260010 |
| FEI number | 3000719653 |
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