Class II — F & A Foundation
| Recalling firm | F & A Foundation (dba Reign Medical) |
|---|---|
| Registered facility | F & A FOUNDATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established. |
| 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 |
| Quantity | 600 |
| Distribution | US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA. |
| Initiated | 2026-07-15 |
| Classified | 2026-09-17 |
| Recall number | Z-3211-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — F & A Foundation (Z-3211-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99515/
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