SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head

The proximal thread depth of the spinal device is out of design specification.

On August 19, 2026, SeaSpine Orthopedics Corporation a subsidiary Orthofix issued a Urgent Medical Device Recall Notification via Email. SeaSpine ask consignees to take the following actions: Actions to be taken by the Customer/User: 1Discontinue use of affected lots 2Immediately 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-3226-2026
• FDA 510(k) clearance · K211606The 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.