{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Lasnitzhohe",
      "state": "",
      "country": "Austria",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98341",
      "recalling_firm": "I.T.S. GmbH",
      "address_1": "Autal 28",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.",
      "recall_number": "Z-1603-2026",
      "product_description": "I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers.     1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13.     2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12.     3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.",
      "product_quantity": "176 units",
      "reason_for_recall": "Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).",
      "recall_initiation_date": "20260123",
      "center_classification_date": "20260320",
      "report_date": "20260401",
      "code_info": "1. Article Number (Lot Numbers): 21301-5 (26/F62569), 21301-7 (26/F62570), 21301-9 (26/F67518), 21301-13 (26/F62568, 26/F67815), 21302-5 (26/F67520), 21302-7 (26/F67821), 21302-9 (26/F62572, 26/F67822), 21302-13 (26/F62571, 26/F67519, 26/F67820).   2. Article Number (Lot Numbers): 21321-7 (26/F54955, 26/F62576), 21321-12 (26/F55883), 21322-7 (26/F55890, 26/F62578), 21322-12 (26/F62577).   3. Article Number (Lot Numbers): 21325-4 (26/F70528, 679/022433, 679/032217, 679/102240, 679/102242, 679/102303), 21325-7 (679/102241, 679/102304).",
      "more_code_info": ""
    }
  ]
}