SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
FDA Recall Z-3226-2026 · Posted 2026-09-18
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Recalling FirmSEASPINE ORTHOPEDICS CORPORATION
Recall StatusOpen, Classified
Product CodeNKB
Date Initiated2026-08-19
Product Quantity270 units
Reason for Recall
The proximal thread depth of the spinal device is out of design specification.
Firm Action
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.
Root Cause
Process design
Distribution Pattern
US Nationwide distribution in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, and Virginia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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