F & A Foundation recalls Reign Medical Clench Staple System
- Recalling company
- F & A Foundation
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 15, 2026
- Reported
- Sep 23, 2026
- Distribution
- US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.
- Status
- Ongoing
- Quantity
- 600
- Lot / codes
- 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
- Company location
- Tulsa, OK
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3211-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3211-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.