Reign Medical Clench Staple System (Compression) recall
F & A Foundation recalled Reign Medical Clench Staple System (Compression) on September 23, 2026 because of bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established. It was sold nationwide.
Why it was recalled
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
What's recalled
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
Quantity: 600
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- F & A Foundation, Tulsa, OK
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA. - Status
- Ongoing
- Recall number
- Z-3211-2026
- Source
- U.S. Food and Drug Administration
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