Official recall notice

FDA DeviceClass IINotable

Extended Polyaxial Head Attached Gimbal Recall (Sep 2026)

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

Recall date
2026-09-30
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Affected products

UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.

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