FDAFDA recall Z-2762-2026 · Jul 29, 2026
SEASPINE ORTHOPEDICS CORPORATION: SeaSpine Polyaxial Head REF Number: 41-3010 recall
Recall found
Product
SeaSpine Polyaxial Head REF Number: 41-3010
Reason for recall
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
- Quantity
- 796 units
- 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.
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION, Carlsbad, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-28
Source: openFDA enforcement record Z-2762-2026 · search recall number Z-2762-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.