Official recall notice
FDA Recall: Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 1
- Recall date
- 2026-09-23
- Brand
- F & A Foundation
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Product description
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Affected products
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