Device recall
Z-0768-2023: Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2 - 5.5 Screw…
FDA device recall · Class II · Acumed LLC
Key facts
| Recall number (Z-number) | Z-0768-2023 |
|---|---|
| Recall event | 90996 |
| Product | Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2 - 5.5 Screw 30-0021-S 25.0mm Acutrak 2 - 5.5 Screw 30-0023 30.0mm Acutrak 2 - 5.5 Screw 30-0023-S 30.0mm Acutrak 2 - 5.5 Screw 30-0025 35.0mm Acutrak 2 - 5.5 Screw 30-0025-S 35.0mm Acutrak 2 - 5.5 Screw 30-0027 40.0mm Acutrak 2 - 5.5… |
| Product code | HWC |
| Recalling firm | Acumed LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K221333 |
| FEI number | 1000125930 |
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