Device recall
Z-3211-2026: Reign Medical Clench Staple System (Compression), Description/REF: 9mm x…
FDA device recall · Class II · F & A Foundation
Key facts
| Recall number (Z-number) | Z-3211-2026 |
|---|---|
| Recall event | 99515 |
| Product | Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20mm x 20mm/152-32020; 9mm x 7mm/152-40907; 11mm x 10mm/152-41110; 15mm x 12mm/152-41512; 18mm x 18mm/152-41818; 20mm x 20mm/152-42020 |
| Product code | JDR |
| Recalling firm | F & A Foundation |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3014527966 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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