Quick Facts at a Glance
- Recall Date
- May 28, 2026
- Hazard Level
- HIGH
- Brand
- SEASPINE ORTHOPEDICS
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SEASPINE ORTHOPEDICS
- Model numbers
- UDI: 10889981155117, Affected Lots: AW199682G, AW199684G.
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 28, 2026
Reported by FDA DEVICE
July 29, 2026
RecallRadar source check
August 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEASPINE ORTHOPEDICS CORPORATION or your healthcare provider for instructions. Notification method: N/A
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Full Description
SeaSpine Polyaxial Head REF Number: 41-3010. Reason: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.. Classification: Class II. 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.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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