Device recall
Z-1595-2026: FR.O.H. Calcaneus Repair System with the following description: Anterolateral…
FDA device recall · Class II · I.T.S. GmbH
Key facts
| Recall number (Z-number) | Z-1595-2026 |
|---|---|
| Recall event | 98341 |
| Product | FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60. |
| Product code | HRS |
| Recalling firm | I.T.S. GmbH |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K051642 |
| FEI number | 3004369035 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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