FDA
Food and Drug Administration · Recall Z-2762-2026 · May 28, 2026SeaSpine Polyaxial Head REF Number: 41-3010
SEASPINE ORTHOPEDICS CORPORATION
The hazard
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
SeaSpine Polyaxial Head REF Number: 41-3010
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI: 10889981155117Model Affected Lots: AW199682GModel AW199684G.UPC 10889981155117Would you have heard about this one?
RapidRecall watches everything you own against every new federal recall and emails you the moment something you bought turns up. Free for your most important items.
Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.