Class II
Medical Device Recall: SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
SEASPINE ORTHOPEDICS CORPORATION · August 19, 2026
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.
States Affected
NATIONWIDE
Quantity Affected
270 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3226-2026
Status: ongoing
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