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

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 info@reignmedical.com

• FDA enforcement recordOfficial FDA database entry for Z-3211-2026
• FDA device classification · JDROfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3030The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find F & A FoundationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.