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

Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.

On 7/15/2026, recall notices were mailed to customers who were asked to do the following: 1) Discontinue use of the affected product immediately. 2) Quarantine any remaining inventory of the recalled product. 3) Follow the attached customer action instructions for guidance on product return. 3) Share this notification with all device users within your facility and network to ensure they are aware of this recall. This notification should also be shared with any organization where the potentially affected devices, or care of patients with potentially affected devices implanted, have been transferred. 4) Follow any recommended patient management or alternative product guidance. Care providers should monitor patients for any adverse events and notify Reign Medical immediately of any such occurrence. 5) Complete and return the response form to [email protected]