{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Plainsboro",
      "address_1": "105 Morgan Ln",
      "reason_for_recall": "T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly.  When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated",
      "address_2": "",
      "product_quantity": "188 units",
      "code_info": "All lot numbers from 2002 to current",
      "center_classification_date": "20120920",
      "distribution_pattern": "Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.",
      "state": "NJ",
      "product_description": "Integra HRAIM Head Ring Assembly with Intubation  Mounts    The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes",
      "report_date": "20120926",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Integra LifeSciences Corporation",
      "recall_number": "Z-2429-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62978",
      "termination_date": "20140326",
      "more_code_info": "",
      "recall_initiation_date": "20120809",
      "postal_code": "08536-3339",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}