Device recall
Z-0610-2017: OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation…
FDA device recall · Class III · OMNI LIFE SCIENCE
Key facts
| Recall number (Z-number) | Z-0610-2017 |
|---|---|
| Recall event | 75499 |
| Product | OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically… |
| Product code | OLO |
| Recalling firm | OMNI LIFE SCIENCE |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 1, 2017 |
| 510(k) numbers | K090953 |
| FEI number | 3008342029 |
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