{"url_path":"/fda/device/recalls/Z-2308-2026","section_key":"summary","section_title":"DEVICE Recall: Grace Medical, Inc. — TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L    Model/Catalog Number: 409-375      Product Description: Stapes Prosthesis","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-03","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2308-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Grace Medical, Inc."},"word_count":72,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2308-2026\n\n**Recalling firm:** Grace Medical, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-03\n**Report date:** 2026-06-10\n\n## Product\nTITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L    Model/Catalog Number: 409-375      Product Description: Stapes Prosthesis\n\n## Reason\nDue to incorrect functional length on device labeling.\n\n## Affected lots\nModel/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927\n\n## Distribution\nU.S Nationwide distribution in the state of MD."}