SeaSpine Polyaxial Head
SeaSpine is recalling the Polyaxial Head due to a manufacturing error that may cause the component to detach during surgery.
Surgeons and hospital staff should immediately stop using the affected components and return them to the manufacturer.
Recall at a glance
- Quantity recalled
- 796 units
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?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
SeaSpine Polyaxial Head REF Number: 41-3010
- Lot code
- AW199682G, AW199684G
- UDI-DI
- 10889981155117
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Manufacturing Deviation recalls
Editorial summary by Recall Canary · summary updated 2026-07-21 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification