{
  "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-1604-2026",
      "product_description": "I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers.  1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4.   2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6.   3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.",
      "product_quantity": "120 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): 21232-3 (26/F65636), 21232-4 (26/F61722, 26/F65637), 21232-6 (26/F62564, 26/F65638), 21233-3 (26/F65639), 21233-4 (26/F65640), 21233-6 (26/F61723, 26/F65046), 21234-4 (26/F65641, 26/F66504), 21235-4 (26/F65642, 26/F67810).   2. Article Number (Lot Numbers): 21231-6 (643/012301, 643/022310, 643/032308, 643/0630, 643/0657, 643/102402, 643/122301).   3. Article Number (Lot Numbers): 37302-18 (18/636447), 37302-20 (18/802189).",
      "more_code_info": ""
    }
  ]
}