SeaSpine Polyaxial Head recall
SeaSpine Polyaxial Head REF Number: 41-3010
Why was SeaSpine Polyaxial Head recalled?
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
- Product
- SeaSpine Polyaxial Head REF Number: 41-3010
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- 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.
- Recall date
- July 29, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)