Device recall
Z-2197-2017: The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons…
FDA device recall · Class II · Acumed LLC
Key facts
| Recall number (Z-number) | Z-2197-2017 |
|---|---|
| Recall event | 77115 |
| Product | The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular… |
| Product code | KWI |
| Recalling firm | Acumed LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 1, 2017 |
| 510(k) numbers | K131845 |
| FEI number | 1000125930 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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