Class 2 Device Recall SeaSpine Mariner Deformity

• Date Initiated by Firm: August 19, 2026
• Date Posted: September 18, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3226-2026
• Recall Event ID: 99691
• 510(K)Number: K211606
• Product Classification: Thoracolumbosacral pedicle screw system - Product Code NKB
• Product: SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
• Code Information: UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
• FEI Number: 3012120772
• Recalling Firm/ Manufacturer: SEASPINE ORTHOPEDICS CORPORATION; 5770 Armada Dr; Carlsbad CA 92008-4608
• For Additional Information Contact: 760-224-0177
• Manufacturer Reason for Recall: The proximal thread depth of the spinal device is out of design specification.
• FDA Determined Cause: Process design
• 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.
• Quantity in Commerce: 270 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NKB