Z-3226-2026Class II

SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

Name: Z-3226-2026 SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Creator: Seaspine Orthopedics Corporation
Published: 2026-08-19
License: https://open.fda.gov/license/

Seaspine Orthopedics Corporation / initiated 2026-08-19 / Open, Classified

FDA source

Recall record

Recall number: Z-3226-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-19
Posted: 2026-09-18
Recalling firm: Seaspine Orthopedics Corporation
Product: SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: The proximal thread depth of the spinal device is out of design specification.
FDA root 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.
Product codes and lots: UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3226-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3226-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18

Product code NKB

K211606Class IIMariner Deformity SystemSeaSpine Orthopedics Corporation / cleared 2021-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)