Device recall
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
- Recall number
- Z-3211-2026
- Event id
- 99515
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- F & A Foundation
- Report date
- Sep 23, 2026
- Posted
- Sep 17, 2026
- Initiated
- Jul 15, 2026
- Center classification date
- Sep 17, 2026
- Product code
- JDR
- Device type
- Staple, Fixation, Bone
- Reason
- Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
- Root cause
- No Marketing Application
- Quantity
- 600
- Code info
- 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
- Distribution
- US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Tulsa, OK, United States