Device recall
Z-0767-2023: Part Number/Part Description: 30-0033-S 30mm Acutrak Fusion Device 6mm Nose…
FDA device recall · Class II · Acumed LLC
Key facts
| Recall number (Z-number) | Z-0767-2023 |
|---|---|
| Recall event | 90996 |
| Product | Part Number/Part Description: 30-0033-S 30mm Acutrak Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak 4/5 Bone Screw AM-0030-S 30.0mm Acutrak 4/5 Bone Screw AM-0035-S 35.0mm Acutrak 4/5 Bone Screw AM-0040-S 40.0mm Acutrak 4/5 Bone Screw AM-0045-S 45.0mm Acutrak 4/5 Bone Screw AM-0050-S 50.0mm Acutrak… |
| 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