Orthofix Srl recalls REF: 99-709245

Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.

No official notification was sent to customers. Orthofix representative was present during the first clinical case and both devices were returned as part of the complaint investigation process.

• FDA enforcement recordOfficial FDA database entry for Z-1977-2025
• FDA 510(k) clearance · K233867The device's official FDA premarket clearance record
• FDA device classification · HSBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3020The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Orthofix SrlSearch 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.