{
  "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": "Diamond particulates may break off the burr and fall into the surgical site.  If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.",
      "address_2": "",
      "product_quantity": "total amount of burrs - 608",
      "code_info": "Model numbers:    GE426R ;  GE426SU ;  GE526R ;  GE526SU ;  GE626R ;  GE626SU ;",
      "center_classification_date": "20170512",
      "distribution_pattern": "US Nationwide distribution - CA, IL, NY, PA, TN, TX",
      "state": "PA",
      "product_description": "GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM;    GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM;    GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM;    GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5;    GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM;    GE626SU; HI-LINE XS DISP.DIAM.BURR X-CRS.III D4.5;     Product Usage:  The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.",
      "report_date": "20170524",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Aesculap Implant Systems LLC",
      "recall_number": "Z-2089-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76988",
      "termination_date": "20180206",
      "more_code_info": "",
      "recall_initiation_date": "20170328",
      "postal_code": "18034-8217",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}