FDAFDA recall Z-3211-2026 · Sep 23, 2026
F & A Foundation: Reign Medical Clench Staple System (Compression) recall
Recall found
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 for recall
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- Quantity
- 600
- Distribution
- US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.
- Recalling firm
- F & A Foundation, Tulsa, OK
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-15
Source: openFDA enforcement record Z-3211-2026 · search recall number Z-3211-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.