CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report
Reign Medical Clench Staple System (Compression), Description recalled
F & A Foundation is recalling Reign Medical Clench Staple System (Compression), Description, distributed nationwide in the US. The recall was initiated on 15 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3211-2026
- FDA event ID
- 99515
- Recalling firm
- F & A Foundation, Tulsa, OK
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Jul 2026
- FDA classified
- 17 Sep 2026
- Reported
- 23 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Jul 2026 | Recall initiated by company | |
| 17 Sep 2026 | Classified by FDA | +64 days |
| 23 Sep 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.
Nationwide LouisianaMassachusettsMarylandOklahomaTexasVermont
Questions about this recall
Why was it recalled?
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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