{"url_path":"/fda/device/recalls/Z-2131-2026","section_key":"summary","section_title":"DEVICE Recall: Orthorebirth Co Ltd — BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC","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-2131-2026%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":102,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2131-2026\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\nBioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC\n\n## Reason\nResorbable bone void filler falls outside standard specifications.\n\n## Affected lots\nUDI-DI: 04573190050552. Lots: 25043001, 25043002, 25043003, 25051401, 25051402, 25051701, 25051702, 25060701, 25060702, 25060703, 25060704, 25083001, 25083002, 25083003, 25083004, 25083005, 25120301, 25122701, 25122702, 26020401 25F07101AA, 25F07103AA, 25F07106AA, 25H27105AA, 25H27107AA, 25H27102AA, 25H27103AA, 25H27104AA, 25K08102AA, 25K08103AA, 25K08101AA, 25J27104AA, 25J27103AA, 25J27102AA, 25J27101AA, 25H27108AA, 25H27101AA\n\n## Distribution\nUS Nationwide distribution in the states of CA, FL."}