{"url_path":"/fda/device/recalls/Z-2132-2026","section_key":"summary","section_title":"DEVICE Recall: Orthorebirth Co Ltd — ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-25","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2132-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Orthorebirth Co Ltd"},"word_count":61,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2132-2026\n\n**Recalling firm:** Orthorebirth Co Ltd\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-25\n**Report date:** 2026-05-13\n\n## Product\nZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z\n\n## Reason\nResorbable bone void filler falls outside standard specifications.\n\n## Affected lots\nUDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF\n\n## Distribution\nUS Nationwide distribution in the states of CA, FL."}