Class IIDeviceOngoing

SEASPINE ORTHOPEDICS CORPORATION

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

Reason for recall

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

Details

Recall number: Z-3226-2026
Event ID: 99691
Recall initiated: Aug 19, 2026
Classified: Sep 18, 2026
Reported: Sep 30, 2026
Quantity: 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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Carlsbad, CA, United States
Lot / code info: UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.