{"recall":{"id":"fda-device-98944","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medacta Usa Inc recalls Short Monobloc Stem Broaches","firm":"Medacta Usa Inc","date":"2026-04-30","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"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","code":"REF/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","quantity":"50","number":"Z-2618-2026","classification":"Class II"}],"reason":"Surgical 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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.","nationwide":true,"states":[],"units":"50","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98944","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"eff915c28063b2fb","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98944","record":[{"status":"Ongoing","city":"Memphis","state":"TN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98944","recalling_firm":"Medacta Usa Inc","address_1":"3973 Delp St","address_2":"N/A","postal_code":"38118-6110","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.","recall_number":"Z-2618-2026","product_description":"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","product_quantity":"50","reason_for_recall":"Surgical 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.","recall_initiation_date":"20260430","center_classification_date":"20260629","report_date":"20260708","code_info":"REF/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"}]}}