FDA Medical devices recall ·
SeaSpine Polyaxial Head recall
- Recall number
- Z-2762-2026
- Date
- (initiated May 28, 2026)
- Company / brand
- Seaspine Orthopedics Corporation
5770 Armada Dr, Carlsbad, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 796 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SeaSpine Polyaxial Head REF Number: 41-3010
Why was it recalled?
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
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: 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 Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2762-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.