Is SEASPINE ORTHOPEDICS CORPORATION recalled?

Yes — a recall has been published. Reason: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

TemporaryFDAOngoing

Can cause harm that is usually temporary.

SeaSpine Polyaxial Head REF Number: 41-3010

Check the device or its packaging for

UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.

Why: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Distributed: Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Mississippi, Montana, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wyoming. The countries of Chile and Australia.
Company: SEASPINE ORTHOPEDICS CORPORATION
Announced: 29 July 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 28 May 2026

Source: FDA record Z-2762-2026 · retrieved 20 July 2026

Every recall is shown word for word from the FDA and USDA, with a link to the source.