{"recall":{"id":"fda-device-99276","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Paragon 28, Inc. recalls P28 PHANTON INTRAMEDULLARY NAIL SYSTEM","firm":"Paragon 28, Inc.","date":"2026-06-17","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.","code":"UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225; UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225; UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725; UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925; UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225.","quantity":"514 units","number":"Z-2758-2026","classification":"Class II"}],"reason":"Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US nationwide, Australia, Canada, The Netherlands, and New Zealand","nationwide":true,"states":[],"units":"514 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=99276","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"8c9ebd690bf123fd","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=99276","record":[{"status":"Ongoing","city":"Englewood","state":"CO","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99276","recalling_firm":"Paragon 28, Inc.","address_1":"14445 Grasslands Dr","address_2":"N/A","postal_code":"80112-7062","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"US nationwide, Australia, Canada, The Netherlands, and New Zealand","recall_number":"Z-2758-2026","product_description":"P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.","product_quantity":"514 units","reason_for_recall":"Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.","recall_initiation_date":"20260617","center_classification_date":"20260717","report_date":"20260729","code_info":"UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225;  UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225;  UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725;  UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925;  UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225."}]}}