Device recall
Z-0892-2026: Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System…
FDA device recall · Class III · Orthofix U.S. LLC
Key facts
| Recall number (Z-number) | Z-0892-2026 |
|---|---|
| Recall event | 97862 |
| Product | Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 9H; 38-1010SP FORZA PTC Spacer… |
| Product code | MAX |
| Recalling firm | Orthofix U.S. LLC |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K172437 |
| FEI number | 2183449 |
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