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SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Polyaxial Head REF Number: 41-3010
Recalled July 29, 2026 · FDA recall Z-2762-2026 · SEASPINE ORTHOPEDICS
Hazard
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. · FDA Class II
Units
796 units
Sold at
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.
Description
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Product
SeaSpine Polyaxial Head REF Number: 41-3010
Manufacturer(s)
SEASPINE ORTHOPEDICS CORPORATION
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →