SeaSpine Polyaxial Head Recall: Risk of Intraoperative Pop-Off

✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the REF Number and affected lots (AW199682G or AW199684G) on the device.

✎ GovInfoNow

Questions people ask

What is the specific model number of the recalled device?

The recalled device is SeaSpine Polyaxial Head REF Number: 41-3010.

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.

Is there a risk of serious injury from this device?

Yes, the device may pop off during surgery, which could lead to complications for patients.

Take action

Contact SeaSpine

We’ve drafted a message you can send SeaSpine to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2762-2026 — SeaSpine SeaSpine

Hello,

I own a SeaSpine that is covered by recall Z-2762-2026 from SeaSpine.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Polyaxial Head REF Number: 41-3010

Use caution until it’s fixed