{"recall":{"id":"fda-device-99707","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":"2026-08-12","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"GM Helix Implant, REF: 109.984;","code":"REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;","quantity":"216","number":"Z-3173-2026","classification":"Class II"}],"reason":"There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;","nationwide":true,"states":[],"units":"216","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=99707","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"2d0840d5b3a9e925","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=99707","record":[{"status":"Ongoing","city":"Andover","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99707","recalling_firm":"Straumann USA LLC","address_1":"60 Minuteman Rd","address_2":"N/A","postal_code":"01810-1008","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;","recall_number":"Z-3173-2026","product_description":"GM Helix Implant, REF: 109.984;","product_quantity":"216","reason_for_recall":"There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.","recall_initiation_date":"20260812","center_classification_date":"20260915","report_date":"20260923","code_info":"REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;","more_code_info":""}]}}