SeaSpine Polyaxial Head
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Seaspine Orthopedics Corporation, based in Carlsbad, California, recalled its Seaspine Polyaxial Head REF Number: 41-3010 due to a manufacturing error that may cause the polyaxial head to popoff from the screw intraoperatively following insertion. The recall began on May 28, 2026, and was added to the FDA's Enforcement Report on July 20, 2026. The product was distributed worldwide, including nationwide in the United States across 25 states, and in Chile and Australia.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
SeaSpine Polyaxial Head REF Number: 41-3010
- UDI-DI
- 10889981155117
- Lot
- AW199682G
- AW199684G
Details
- Company began the recall
- Sold in
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.
- Event ID
- 99221
- Recall No.
- Z-2762-2026
- Company
- SEASPINE ORTHOPEDICS CORPORATIONCarlsbad, California
- Hazard
- Manufacturing deviation
- Quantity recalled
- 796 units
- Recall type
- Voluntary: Firm initiated
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
