Device recall
Z-0769-2023: AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm…
FDA device recall · Class II · Acumed LLC
Key facts
| Recall number (Z-number) | Z-0769-2023 |
|---|---|
| Recall event | 90996 |
| Product | AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist Acutrak Compression Screw AI-0012-S 12mm AcuTwist Acutrak Compression Screw AI-0014-S 14mm AcuTwist Acutrak Compression Screw AI-0016-S 16mm AcuTwist Acutrak Compression Screw AI-0018-S 18mm AcuTwist 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