Medical 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/15
F & A Foundation · July 15, 2026
Reason for Recall
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Product Description
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
Distribution
US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.
States Affected
NATIONWIDE
Quantity Affected
600
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3211-2026
Status: ongoing
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