{"url_path":"/fda/device/recalls/Z-2618-2026","section_key":"summary","section_title":"DEVICE Recall: Medacta Usa Inc — Short Monobloc Stem Broaches, Size/REF:  7/04.01.10.0970,  8/04.01.10.0971,  9/04.01.10.0972,  10/04.01.10.0973,  11/04.01.10.0974,  12/04.01.10.0975,  13/04.01.10.0976,  14/04.01.10.0977,  15/04.01.10.0978,  16/04.01.10.0979    Part of Medacta Shoulder System","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-30","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2618-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medacta Usa Inc"},"word_count":126,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2618-2026\n\n**Recalling firm:** Medacta Usa Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-30\n**Report date:** 2026-07-08\n\n## Product\nShort Monobloc Stem Broaches, Size/REF:  7/04.01.10.0970,  8/04.01.10.0971,  9/04.01.10.0972,  10/04.01.10.0973,  11/04.01.10.0974,  12/04.01.10.0975,  13/04.01.10.0976,  14/04.01.10.0977,  15/04.01.10.0978,  16/04.01.10.0979    Part of Medacta Shoulder System\n\n## Reason\nSurgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.\n\n## Affected lots\nREF/UDI/Lot: 04.01.10.0970/07630542768910/2585086, 04.01.10.0971/07630542768927/2585087, 04.01.10.0972/07630542768934/2585088, 04.01.10.0973/07630542768941/2585089, 04.01.10.0974/07630542768958/2585090, 04.01.10.0975/07630542768965/2585091, 04.01.10.0976/07630542768972/2585092, 04.01.10.0977/07630542768989/2585093, 04.01.10.0978/07630542768996/2585094, 04.01.10.0979/07630542769009/2585095\n\n## Distribution\nUS Nationwide distribution in the states of CO, AR, IN, PA, UT, FL."}