Official recall notice

FDA DeviceClass IINotable

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

Recall date
2026-07-29
FDA class
Class II

Why it was recalled

Hazard

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

Product description

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

Affected products

UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.

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