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MEDICAL DEVICE RECALLMODERATE
SeaSpine Polyaxial Head
SeaSpine is recalling the Polyaxial Head due to a manufacturing error that may cause the component to detach during surgery.
What to do
Surgeons and hospital staff should immediately stop using the affected components and return them to the manufacturer.
Why it was recalled
SeaSpine is recalling the Polyaxial Head due to a manufacturing error that may cause the component to detach from the screw during surgery following insertion.
Is mine affected?
This recall covers the product below. If you have it, yours is affected.
SeaSpine Polyaxial Head REF Number: 41-3010
Official source
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Editorial summary by Recall Canary · last updated 2026-07-21 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification