{
  "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: GP190R  GP201R  GP202R  GP203R  GP204R  GP205R  GP208R  GP209R  GP210R  GP210TC  GP211R  GP212R  GP213R  GP214R  GP215R  GP216R  GP217R  GP218R  GP219R  GP220R  GP341R  GP342R  GP343R  GP351R  GP352R  GP353R  GP361R  GP362R  GP363R  GP364R  GP367R  GP367TC  GP370R  GP371R  GP398SU  GP399TC-SU  GP491R  GP492R  GP493R  GP494R  GP495R  GP496R  GP497R  GP542R  GP543R  GP544R  GP545R  US779R  US780R  US781R  US782R  US784TC  US792R  US793R  US794R  US795R  US798TC  US799TC  US800R",
      "center_classification_date": "20180215",
      "distribution_pattern": "Distributed to 4 hospitals in the following states: NM, OH, TX, WV",
      "state": "PA",
      "product_description": "ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0  ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5  ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0  ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5   ELAN 4 1-RING NEURO CUTTER SOFT D3.0  ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0  ELAN 4 1-RING NEURO CUTTER D2.0   ELAN 4 1-RING NEURO CUTTER D2.5   ELAN 4 1-RING NEURO CUTTER D3.0   ELAN 4 1-RING NEURO CUTTER TC D3.0  ELAN 4 1-RING NEURO CUTTER DIAM.D1.5  ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5  ELAN 4 1-RING NEURO CUTTER DIAM.D2.0  ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0  ELAN 4 1-RING NEURO CUTTER DIAM.D2.5  ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5  ELAN 4 1-RING NEURO CUTTER DIAM.D3.0  ELAN 4 1-RING NEURO CUTTER+ DIAM.D3.0  ELAN 4 1-RING NEURO CUTTER DIAM.D4.0  ELAN 4 1-RING NEURO CUTTER+ DIAM.D4.0  ELAN 4 2-RING CRANIOTOME CUTTER PAED  ELAN 4 2-RING CRANIOTOME CUTTER STANDARD  ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING CRANIOTOME CUTTER PAED  ELAN 4 2-RING CRANIOTOME CUTTER STANDARD  ELAN 4 2-RING CRANIOTOME CUTTER LONG  ELAN 4 2-RING NEURO CUTTER SOFT D2,0  ELAN 4 2-RING NEURO CUTTER SOFT D2,5  ELAN 4 2-RING NEURO CUTTER SOFT D3,0  ELAN 4 2-RING NEURO CUTTER+ SOFT D3,0  ELAN 4 2-RING NEURO CUTTER SOFT D3,0  ELAN 4 2-RING NEURO CUTTER TC D3,0  ELAN 4 2-RING NEURO CUTTER DIAM. D3,0  ELAN 4 2-RING NEURO CUTTER+ DIAM. D3,0  ELAN 4 2-RING DIAMOND DISC  ELAN 4 2-RING SIDE CUTTER TC D3,0  SAW BLADE S sagittal 11/13/0,3  SAW BLADE S sagittal 15/5/0,3  SAW BLADE S sagittal 20/5/0,3  SAW BLADE S sagittal 20/10/0,3  SAW BLADE S sagittal 20/15/0,3  SAW BLADE S sagittal 25/5/0,3  SAW BLADE S sagittal 25/12/0,3  RECIPROCATING SAW BLADE MICRO 13/0.3  RECIPROCATING SAW BLADE MICRO 20/0.3  RECIPROCATING SAW BLADE MICRO 13/0.3  RECIPROCATING SAW BLADE MICRO 20/0.3  ELAN 4 1-RING NEURO CUTTER D1.5+  ELAN 4 1-RING NEURO CUTTER D2.0+  ELAN 4 1-RING NEURO CUTTER D2.5+  ELAN 4 1-RING NEURO CUTTER D3.0+  ELAN 4 1-RING SIDE CUTTING, CARBIDE D2.0  ELAN 4 1-RING NEURO PRECISE D1.5  ELAN 4 1-RING NEURO PRECISE D2.0  ELAN 4 1-RING NEURO PRECISE D2.5  ELAN 4 1-RING NEURO PRECISE D3.0  ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D0.8  ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D1.7 ELAN 4 NEURO PRECISE D 1.5",
      "report_date": "20180221",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Aesculap Implant Systems LLC",
      "recall_number": "Z-0621-2018",
      "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"
    }
  ]
}