SEASPINE ORTHOPEDICS CORPORATION — SeaSpine Polyaxial Head REF Number: 41-3010
⚠️ Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 28, 2026
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.
What's affected?
- Product
- SeaSpine Polyaxial Head REF Number: 41-3010
- Lot code
- AW199682G
Additional details
UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 796 units.
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