{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Center Valley",
      "address_1": "3773 Corporate Pkwy",
      "reason_for_recall": "ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.",
      "address_2": "",
      "product_quantity": "6211",
      "code_info": "All lots, Model Number: GP188R  GP189R  GP344R  GP345R  GP346R  GP347R  GP348R  GP349R  US804R  US805R  US806R  US828R  US829R  US830R",
      "center_classification_date": "20180215",
      "distribution_pattern": "Distributed to 4 hospitals in the following states: NM, OH, TX, WV",
      "state": "PA",
      "product_description": "ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5  ELAN 4 1-RING TWIST DRILL D2.0  ELAN 4 2-RING TWIST DRILL D1,0/4,0MM  ELAN 4 2-RING TWIST DRILL D1,1/4,0MM  ELAN 4 2-RING TWIST DRILL D1,2/4,0MM  ELAN 4 2-RING TWIST DRILL D1,5/4,0MM  ELAN 4 2-RING TWIST DRILL D1,5  ELAN 4 2-RING TWIST DRILL D2,0  ELAN 4 2-RING WIRE PASS DRILL D1.0  ELAN 4 2-RING WIRE PASS DRILL D1.5  ELAN 4 2-RING WIRE PASS DRILL D2.0  ELAN 4 2-RING WIRE PASS DRILL D1.0  ELAN 4 2-RING WIRE PASS DRILL D1.5  ELAN 4 2-RING WIRE PASS DRILL D2.0",
      "report_date": "20180221",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Aesculap Implant Systems LLC",
      "recall_number": "Z-0620-2018",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "79068",
      "termination_date": "20190920",
      "more_code_info": "",
      "recall_initiation_date": "20170905",
      "postal_code": "18034-8217",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}