Recall Z-3211-2026 ยท JDR Staple, Fixation, Bone
F & A Foundation
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
| Date | Sep 17, 2026 (initiated Jul 15, 2026) |
| Status | Open, Classified |
| Reason | Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established. |
| Root cause | No Marketing Application |
| Action | On 7/15/2026, recall notices were mailed to customers who were asked to do the following: 1) Discontinue use of the affected product immediately. 2) Quarantine any remaining inventory of the recalled product. 3) Follow the attached customer action instructions for guidance on product return. 3) Share this notification with all device users within your facility and network to ensure they are aware of this recall. This notification should also be shared with any organization where the potentially affected devices, or care of patients with potentially affected devices implanted, have been t |
| Quantity | 600 |
| Distribution | US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.