FDA Device recall Z-3211-2026
Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907 by F And A Foundation, citing bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3211-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-15 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | F And A Foundation |
| Distribution | US |
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.
Identifiers
| code_info | REF/UDI-DI/Lot/Expiration: 152-30907/00854325007011/24-0627/10/27/2029, 152-31110/00854325007028/24-0628/10/21/2029,…REF/UDI-DI/Lot/Expiration: 152-30907/00854325007011/24-0627/10/27/2029, 152-31110/00854325007028/24-0628/10/21/2029, 152-31512/00854325007042/24-0629/10/22/2029, 152-31818/00854325007073/24-0630/10/23/2029, 152-32020/00854325007189/24-0631/10/28/2029, 152-40907/00854325007010/24-0633/10/16/2029, 152-41110/00854325007127/24-0634/10/20/2029, 152-41512/00854325007141/24-0635/10/20/2029, 152-41818/00854325007172/24-0636/10/16/2029, 152-42020/00854325007189/24-0637/10/16/2029 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3211-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.