Device recall
Z-2718-2024: Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System…
FDA device recall · Class II · Treace Medical Concepts, Inc.
Key facts
| Recall number (Z-number) | Z-2718-2024 |
|---|---|
| Recall event | 94977 |
| Product | Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component. |
| Product code | HRS |
| Recalling firm | Treace Medical Concepts, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K240173 |
| FEI number | 3011623994 |
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