{"recall":{"id":"fda-device-99504","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Paragon 28, Inc. recalls 2 products","firm":"Paragon 28, Inc.","date":"2026-07-10","reported":"2026-08-26","status":"Ongoing","classification":"Class III","products":[{"name":"Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant","code":"Lot Number AOCIA6123","quantity":"1","number":"Z-2971-2026","classification":"Class III"},{"name":"Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant","code":"Lot Number AOCIA6123","quantity":"1 unit","number":"Z-2972-2026","classification":"Class III"}],"reason":"Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"US Nationwide distribution i the state of MT.","nationwide":true,"states":[],"units":"1; 1 unit","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=99504","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"5dd97f4a50652265","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=99504","record":[{"status":"Ongoing","city":"Englewood","state":"CO","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99504","recalling_firm":"Paragon 28, Inc.","address_1":"14445 Grasslands Dr","address_2":"","postal_code":"80112-7062","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution i the state of MT.","recall_number":"Z-2971-2026","product_description":"Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant","product_quantity":"1","reason_for_recall":"Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.","recall_initiation_date":"20260710","center_classification_date":"20260814","report_date":"20260826","code_info":"Lot Number AOCIA6123","more_code_info":""},{"status":"Ongoing","city":"Englewood","state":"CO","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99504","recalling_firm":"Paragon 28, Inc.","address_1":"14445 Grasslands Dr","address_2":"","postal_code":"80112-7062","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution i the state of MT.","recall_number":"Z-2972-2026","product_description":"Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant","product_quantity":"1 unit","reason_for_recall":"Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.","recall_initiation_date":"20260710","center_classification_date":"20260814","report_date":"20260826","code_info":"Lot Number AOCIA6123","more_code_info":""}]}}