Reported Jul 29, 2026 · Ongoing
SeaSpine Polyaxial Head REF Number: 41-3010
Seaspine Orthopedics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SEASPINE ORTHOPEDICS CORPORATION · 5770 Armada Dr · Carlsbad, CA · 92008-4608
Is this the product you have?
- SeaSpine Polyaxial Head REF Number41-3010
- Lot codes and dates
- UDI10889981155117
- Affected Lots
AW199682GAW199684G
- Amount recalled
- 796 units
Where it was sold
Why it was recalled
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
This product could cause temporary or reversible health problems — stop using it.
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