Recall Z-3211-2026— F & A Foundation
Class II · Ongoing
Class II FDA medical device recall by F & A Foundation, initiated 2026-07-15. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established..
- Recalling firm
- F & A Foundation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-15
- Firm location
- Tulsa, OK, United States
Product description
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
Reason for recall
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Data sourced from openFDA. This site is unofficial and independent of the FDA.