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Ongoing FDAEvent 99515 (28 days ago)

F & A Foundation Reign Medical Clench Staple System (Compression)

The Reign Medical Clench Staple System has not had its performance characteristics adequately established.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

F & A Foundation of Tulsa, Oklahoma, began a recall of the Reign Medical Clench Staple System (Compression) on July 15, 2026, because the bone fixation staple requires a new 510(k) and its performance characteristics have not been adequately established. The FDA added the recall to its Enforcement Report and classified it on September 17, 2026, with the weekly report on September 23, 2026. The device was distributed in the states of TX, OK, MD, VT, MA, LA.

Summary by Recall Canary from the FDA notice.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Affected if its UDI-DI and lot code are listed under that product.

  1. Reign Medical Clench Staple System (Compression), Description/REF

    UDI-DI
    • 00854325007011
    • 00854325007028
    • 00854325007042
    • 00854325007073
    • 00854325007189
    • 00854325007010
    • 00854325007127
    • 00854325007141
    • 00854325007172
    Lot
    • 152-30907
    • 24-0627
    • 152-31110
    • 24-0628
    • 152-31512
    • 24-0629
    • 152-31818
    • 24-0630
    • 152-32020
    • 24-0631
    • 152-40907
    • 24-0633
    • 152-41110
    • 24-0634
    • 152-41512
    • 24-0635
    • 152-41818
    • 24-0636
    • 152-42020
    • 24-0637

Details

Company began the recall
Sold in

US Nationwide distribution in the states of Texas, Oklahoma, Maryland, Vermont, Massachusetts, Louisiana.

Event ID
99515
Recall No.
Z-3211-2026
Company
F & A FoundationTulsa, Oklahoma
Hazard
Device defect

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Other device defect recalls

See all

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration