{"recall":{"id":"fda-device-99441","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Straumann USA LLC recalls Straumann Bone Level Tapered (BLT) Implant","firm":"Straumann USA LLC","date":"2026-07-16","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form","code":"UDI/DI 7630031707055, Lot ZVFV5","quantity":"175 units","number":"Z-2935-2026","classification":"Class II"}],"reason":"Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"175 units","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=99441","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"23e6c80be55b6473","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=99441","record":[{"status":"Ongoing","city":"Andover","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99441","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.","recall_number":"Z-2935-2026","product_description":"Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form","product_quantity":"175 units","reason_for_recall":"Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.","recall_initiation_date":"20260716","center_classification_date":"20260811","report_date":"20260819","code_info":"UDI/DI 7630031707055, Lot ZVFV5","more_code_info":""}]}}