Compare the complete identifiers. Name similarity alone is not a confirmed match.
SeaSpine Polyaxial Head REF Number: 41-3010
| Product or model | Codes and lots | Quantity | Recall number |
|---|---|---|---|
| SeaSpine Polyaxial Head REF Number: 41-3010 | UDI: 10889981155117; Affected Lots: AW199682G, AW199684G. | 796 units | Z-2762-2026 |
The agency's statement is shown without a site-authored severity score.
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Agency classification: Class II
Only instructions associated with this recall event qualify as an action.
Consumer action is not available in the associated official record. The site does not infer or generate a replacement.
The linked agency record controls if any information differs.
Official scope
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.
Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.
No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.
