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

Medical DevicesSource: FDA (device) · Date: 2026-09-30

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
SEASPINE ORTHOPEDICS CORPORATION
Product
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Reason / hazard
The proximal thread depth of the spinal device is out of design specification.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-08-19
Code info
UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
Product quantity
270 units
Voluntary mandated
Voluntary: Firm initiated
City
Carlsbad
State
CA
Country
United States
Event id
99691
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