{"url_path":"/fda/device/recalls/Z-2762-2026","section_key":"summary","section_title":"DEVICE Recall: SEASPINE ORTHOPEDICS CORPORATION — SeaSpine Polyaxial Head  REF Number: 41-3010","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-28","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2762-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"SEASPINE ORTHOPEDICS CORPORATION"},"word_count":103,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2762-2026\n\n**Recalling firm:** SEASPINE ORTHOPEDICS CORPORATION\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-28\n**Report date:** 2026-07-29\n\n## Product\nSeaSpine Polyaxial Head  REF Number: 41-3010\n\n## Reason\nDue to manufacturing error, polyaxial  head may popoff  from the screw intraoperatively following insertion.\n\n## Affected lots\nUDI: 10889981155117; Affected Lots: AW199682G, AW199684G.\n\n## Distribution\nWorldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Mississippi, Montana, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wyoming. The countries of Chile and Australia."}