Device recall
Z-1717-2019: OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics…
FDA device recall · Class II · OMNIlife science Inc.
Key facts
| Recall number (Z-number) | Z-1717-2019 |
|---|---|
| Recall event | 82797 |
| Product | OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit… |
| Product code | OLO |
| Recalling firm | OMNIlife science Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 14, 2020 |
| 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