SeaSpine Polyaxial Head Recall: Risk of Intraoperative Pop-Off
SeaSpine recalls polyaxial heads with REF 41-3010 due to potential pop-off during surgery. Affected lots include AW199682G and AW199684G. Contact for replacement.
Use caution until it’s fixed
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
What happened, in plain English
SeaSpine is recalling a specific type of surgical head that could detach during surgery due to a manufacturing error. This poses a risk of complications for patients undergoing procedures. Read more at govinfonow.com/recall/127866-seaspine-polyaxial-head-recall-risk-of-intraoperative-pop-off.
Source Summary by GovInfoNow · govinfonow.com/recall/127866-seaspine-polyaxial-head-recall-risk-of-intraoperative-pop-off · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2762-2026
Cite this page
“SeaSpine Polyaxial Head Recall: Risk of Intraoperative Pop-Off.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/127866-seaspine-polyaxial-head-recall-risk-of-intraoperative-pop-off. Based on FDA recall #Z-2762-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2762-2026%22&limit=1).
Why it’s dangerous
The polyaxial head may detach from the screw during surgery due to a manufacturing error. This could lead to complications for patients if the head becomes dislodged during the procedure.
Who’s affected
Surgical teams using SeaSpine Polyaxial Heads with REF Number 41-301: 41-3010 are affected. Patients undergoing surgery with these devices are at risk of complications.
How to tell if you have this one
Check for the REF Number 41-3010 on the product. Affected lots are AW199682G and AW199684G. The device has a unique identifier (UDI) starting with 10889981155117.
- Brand
SeaSpine- Category
Medical device
What to do — step by step
Check Product Details
Verify the REF Number and affected lots (AW199682G or AW199684G) on the device.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 25 states.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Mississippi, Missouri, Montana, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the recalled device?
Contact SeaSpine directly to confirm if your device is affected and get instructions for replacement.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2762-2026 (May 28, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2762-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.