Medical Device Recall: SeaSpine Polyaxial Head REF Number: 41-3010
SEASPINE ORTHOPEDICS CORPORATION · May 28, 2026
Reason for Recall
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
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.
States Affected
NATIONWIDE
Quantity Affected
796 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2762-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.