{
  "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": "10984",
      "code_info": "All lots, Model Number: GP111R  GP112R  GP113R  GP113TC  GP114R  GP115R  GP116R  GP117R  GP118R  GP119TC  GP120R  GP121R  GP122R  GP123R  GP124R  GP124TC  GP125R  GP126R  GP126TC  GP127R  GP128R  GP128TC  GP129R  GP129TC  GP133R  GP134R  GP135R  GP136R  GP141R  GP142R  GP143R  GP144R  GP145R  GP146R  GP147R  GP148R  GP149R  GP150R  GP151R  GP152R  GP153R  GP154R  GP155R  GP156R  GP157R  GP158R  GP161R  GP162R  GP163R  GP164R  GP165R  GP166R  GP167R  GP168R  GP169R  GP170R  GP173R  GP174R  GP175R  GP176R  GP177R  GP184R  GP185R  GP186R  GP187R  GP193R  GP194R  GP195R  GP196R  GP224R  GP225R  GP226R  GP228R  GP229R  GP230R  GP232R  GP233R  GP234R  GP235R  GP236R  GP238R  GP240R  GP241R  GP242R  GP243R  GP301R  GP301TC  GP302R  GP302TC  GP303R  GP304R  GP304TC  GP305R  GP306R  GP306TC  GP307R  GP307TC  GP308R  GP308TC  GP309R  GP309TC  GP311R  GP312R  GP313R  GP314R  GP315R  GP316R  GP317R  GP321R  GP322R  GP323R  GP324R  GP325R  GP328R  GP329R  GP330R  GP335R  GP336R  GP337R  GP338R  GP339R  GP350R  GP355R  GP356R  GP357R  GP358R  GP374R  GP375R  GP376R  GP378R  GP379R  GP380R  GP382R  GP384R  GP385R  GP386R  GP388R  GP389R  GP391R  GP392R  GP393R  GP395TC  GP397R  US792R  US793R  US794R  US771R  US772R  US773R  US774R  US775R  US776R  US777R  US783TC  US785TC  US787R  US788TC  US790TC  US800R  US801R  US807R  US852TC  US853R  US861R  US825R  US831R",
      "center_classification_date": "20180215",
      "distribution_pattern": "Distributed to 4 hospitals in the following states: NM, OH, TX, WV",
      "state": "PA",
      "product_description": "ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6  ELAN 4 1-RING ROSEN BURR+ D0.8  ELAN 4 1-RING ROSEN BURR D1.0  ELAN 4 1-RING ROSEN BURR TC D1.0  ELAN 4 1-RING ROSENBURR+ D1.0  ELAN 4 1-RING ROSEN BURR D1.4  ELAN 4 1-RING ROSENBURR+ D1.4  ELAN 4 1-RING ROSEN BURR D1.8  ELAN 4 1-RING ROSEN BURR+ D1.8  ELAN 4 1-RING ROSEN BURR TC D2.0  ELAN 4 1-RING ROSEN BURR D2.3  ELAN 4 1-RING ROSEN BURR+ D2.3  ELAN 4 1-RING ROSEN BURR D2.7  ELAN 4 1-RING ROSEN BURR+ D2.7  ELAN 4 1-RING ROSEN BURR D3.0  ELAN 4 1-RING ROSEN BURR TC D3.0  ELAN 4 1-RING ROSEN BURR D3.5",
      "report_date": "20180221",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Aesculap Implant Systems LLC",
      "recall_number": "Z-0619-2018",
      "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"
    }
  ]
}