F & A Foundation Reign Medical Clench Staple System Recall: Bone Fixation Risk
F & A Foundation recalls Reign Medical Clench Staple Systems (compression) due to unverified bone fixation safety. Affected models include 9mm x 7mm, 11mm x 10mm, and others with specific lot numbers. No remedy specified in recall notice.
Recall notice
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
What happened, in plain English
F & A Foundation is recalling their Reign Medical Clench Staple System (compression) because the device's bone fixation capabilities haven't been properly tested for safety. This could lead to improper healing or injury if used without adequate medical validation. Read more at govinfonow.com/recall/1134733-f-a-foundation-reign-medical-clench-staple-system-recall-bone.
Source Summary by GovInfoNow · govinfonow.com/recall/1134733-f-a-foundation-reign-medical-clench-staple-system-recall-bone · Updated October 4, 2026 · FDA enforcement record: FDA #Z-3211-2026
Cite this page
“F & A Foundation Reign Medical Clench Staple System Recall: Bone Fixation Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/1134733-f-a-foundation-reign-medical-clench-staple-system-recall-bone. Based on FDA recall #Z-3211-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3211-2026%22&limit=1).
Why it’s dangerous
The device requires a new FDA 510(k) clearance for bone fixation, but the manufacturer hasn't established its safety and effectiveness for this purpose. Without proper testing, the staples could cause improper bone alignment or injury during healing.
Who’s affected
Medical professionals using the Reign Medical Clench Staple System for bone fixation procedures are most at risk. Patients who have received this device for surgical applications may also be affected.
How to tell if you have this one
Check for model numbers like 9mm x 7mm/152-30907, 11mm x 10mm/152-31110, or 15mm x 12mm/152-31512. The product was sold with specific lot numbers and expiration dates listed in the recall notice.
- Brand
F & A Foundation- Category
Medical device
What to do — step by step
Check Product Details
Look for model numbers and lot numbers on the device packaging or label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
FDA distribution: “US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Louisiana, Maryland, Massachusetts, Oklahoma, Texas, Vermont.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3211-2026 (July 15, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3211-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.