{"recall":{"id":"fda-device-99407","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Straumann USA LLC recalls GM Helix Implant","firm":"Straumann USA LLC","date":"2026-07-13","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"GM Helix Implant, Endosseous Dental Implant Article No. 109.984","code":"UDI-DI 7899878024552 Lot MVXJ9","quantity":"417 US","number":"Z-2929-2026","classification":"Class II"}],"reason":"There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.","nationwide":true,"states":[],"units":"417 US","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=99407","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7daa46f8026447ea","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=99407","record":[{"status":"Ongoing","city":"Andover","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99407","recalling_firm":"Straumann USA LLC","address_1":"60 Minuteman Rd","address_2":"","postal_code":"01810-1008","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.","recall_number":"Z-2929-2026","product_description":"GM Helix Implant, Endosseous Dental Implant  Article No. 109.984","product_quantity":"417 US","reason_for_recall":"There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume","recall_initiation_date":"20260713","center_classification_date":"20260810","report_date":"20260819","code_info":"UDI-DI 7899878024552 Lot MVXJ9","more_code_info":""}]}}