SeaSpine Polyaxial Head REF Number: 41-3010
Pending LLM rewrite. Source: FDA_DEVICE Z-2762-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
The recalled product
- Product
- SeaSpine Polyaxial Head REF Number: 41-3010
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI: 10889981155117
- Affected Lots: AW199682G
- AW199684G.
Distribution
Distributed nationwide across the United States.
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