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SeaSpine Mariner Deformity Product Name recall

SEASPINE ORTHOPEDICS CORPORATION recalled SeaSpine Mariner Deformity Product Name on September 30, 2026 because of the proximal thread depth of the spinal device is out of design specification. It was sold nationwide.

Why it was recalled

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

What's recalled

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

Quantity: 270 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
SEASPINE ORTHOPEDICS CORPORATION, Carlsbad, CA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
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.
Status
Ongoing
Recall number
Z-3226-2026
Source
U.S. Food and Drug Administration

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