FDAFDA · Food and drugs·Recall number Z-2762-2026
SeaSpine Polyaxial Head REF Number: 41-3010
Published July 29, 2026 · Recall initiated: May 28, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Distributor
- 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.
- Lot
- UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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