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

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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

Provider: FDA — device enforcement reference
Source observed: 8/19/2026, 12:00:00 AM UTC
Source updated: 9/18/2026, 12:00:00 AM UTC
Location: Carlsbad, CA, US
hazard: The proximal thread depth of the spinal device is out of design specification.
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
product: SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
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.
event number: 99691
manufacturer: SEASPINE ORTHOPEDICS CORPORATION
recall number: Z-3226-2026
source status: Open, Classified
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

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