SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Polyaxial Head REF Number: 41-3010
- Recalling company
- SEASPINE ORTHOPEDICS CORPORATION
- Product
- SeaSpine Polyaxial Head REF Number: 41-3010
- Reason
- Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 28, 2026
- Reported
- Jul 29, 2026
- 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.
- Status
- Ongoing
- Quantity
- 796 units
- Lot / codes
- UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
- Company location
- Carlsbad, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2762-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2762-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.