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Z-2762-2026Class II

SEASPINE ORTHOPEDICS CORPORATION

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
SEASPINE ORTHOPEDICS CORPORATION
Product type
Device
Status
Ongoing
Report date
2026-07-29
Distribution
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.
Firm state
CA
Product quantity
796 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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

Product description

SeaSpine Polyaxial Head REF Number: 41-3010

Code / lot info

UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.

Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →