FDA DeviceClass IINotable

FDA Recall: SeaSpine Polyaxial Head REF Number: 41-3010

Date: 2026-07-29
Brand: SEASPINE ORTHOPEDICS CORPORATION
Category: Medical Device
FDA Class: Class II

Description

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Hazard

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Remedy

796 units

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