SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Polyaxial Head REF Number: 41-3010

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

SeaSpine Polyaxial Head REF Number: 41-3010

On June 16, 2026, Orthofix issued a updated Urgent Medical Device Recall notification to provide additional information concerning the recall. Initial notification was issued on May 28, 206. Orthofix ask consignees to take the following actions: 1. Discontinue use of affected lots, 2.Immediately identify and quarantine any affected product. 3. If product is identified, Orthofix will facilitate the return. 4. Complete and return the attached Acknowledgement and Receipt Form. 5. This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred.

• FDA enforcement recordOfficial FDA database entry for Z-2762-2026
• FDA 510(k) clearance · K173882The device's official FDA premarket clearance record
• FDA device classification · NKBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3070The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find SEASPINE ORTHOPEDICS CORPORATIONSearch 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.