SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Summary
The FDA issued a Class II for SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gim by SEASPINE ORTHOPEDICS CORPORATION. Reason: The proximal thread depth of the spinal device is out of design specification..
Details
Source
Device Recall
External ID
Z-3226-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
Product Description
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Lot/Code Info: UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
Quantity Affected: 270 units
Reason for Recall
The proximal thread depth of the spinal device is out of design specification.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-19
Company
Carlsbad, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
SEASPINE ORTHOPEDICS CORPORATION has 28 FDA actions in our database, including 11 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SEASPINE ORTHOPEDICS CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SEASPINE ORTHOPEDICS CORPORATION have FDA actions?
SEASPINE ORTHOPEDICS CORPORATION has 28 FDA actions in our database, including 11 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3226-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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