Device recall
Z-1038-2026: Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
FDA device recall · Class II · Medicrea International
Key facts
| Recall number (Z-number) | Z-1038-2026 |
|---|---|
| Recall event | 97996 |
| Product | Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 |
| Product code | MAX |
| Recalling firm | Medicrea International |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K241164 |
| FEI number | 1000432246 |
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