Reign Medical Clench Staple System (Compression) recall — F & A Foundation
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Official ID Z-3211-2026 · Official record ↗
Recall found. F & A Foundation is named in FDA Class II recall Z-3211-2026 covering Reign Medical Clench Staple System (Compression). Hazard: Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established. Identifying details: 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: Ongoing.
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Official ID Z-3211-2026 · Official record ↗
Found something wrong or missing? Report a data error.
Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.