{"url_path":"/fda/device/recalls/Z-2524-2026","section_key":"summary","section_title":"DEVICE Recall: TMJ Solutions Inc — TMJ Bilateral Implants, REF: CHG020","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-02-11","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2524-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"TMJ Solutions Inc"},"word_count":75,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2524-2026\n\n**Recalling firm:** TMJ Solutions Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-02-11\n**Report date:** 2026-07-01\n\n## Product\nTMJ Bilateral Implants, REF: CHG020\n\n## Reason\nCustom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.\n\n## Affected lots\nUDI-DI: 07613327626575, Lot: 2508181038\n\n## Distribution\nUS Nationwide distribution in the state of MA."}