{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Altstatten Sg",
      "state": "",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93577",
      "recalling_firm": "Icotec Ag",
      "address_1": "Industriestrasse 12",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US:  AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA",
      "recall_number": "Z-0700-2024",
      "product_description": "VADER pedicle system, torque wrench, Catalog Number 42-702",
      "product_quantity": "79 devices (US only)",
      "reason_for_recall": "icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.",
      "recall_initiation_date": "20231128",
      "center_classification_date": "20240110",
      "report_date": "20240117",
      "code_info": "19/01-001, 19/01-013, 19/01-014, 19/01-015, 190830-10, 190830-23, 190830-42, 190830-44, 190830-45, 190830-50, 190830-51, 190830-52, 200131-54, 200131-56, 200131-62, 200131-64, 200131-68, 200131-69, 200131-70, 200131-72, 200131-73, 200131-74, 200221-040R1, 200424-01, 200424-03, 200424-04, 200424-05, 200424-06, 200424-10, 200424-11, 200424-12, 200424-13, 200424-14, 200424-15, 200424-16, 200424-17, 200424-20, 200424-21, 200424-22, 200424-24, 200424-25, 200424-27, 200424-29, 200424-32, 200424-34, 200424-35, 200605-051R1, 200605-052R1, 201002-073R1, 210915-005, 210915-009, 210915-010, 210915-011, 210915-012, 220610-001, 220610-003, 220610-008, 220610-019, 220610-020, 220610-021, 220610-025, 220610-026, 220610-030, 230113-003, 230113-005, 230113-007, 230113-008, 230113-009, 230113-010, 230113-011, 230113-012, 230113-013, 230113-014, 230224-029, 230224-034, 230426-038, 230426-039, 230426-042, 230426-043",
      "more_code_info": ""
    }
  ]
}