{
  "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": [
    {
      "status": "Terminated",
      "city": "Vienna",
      "state": "N/A",
      "country": "Austria",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79019",
      "recalling_firm": "Otto Bock Healthcare Product",
      "address_1": "Brehmstrase 16",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA  AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU",
      "recall_number": "Z-0815-2018",
      "product_description": "OTTO BOCK Kenevo knee joints Model 3C60=ST",
      "product_quantity": "4",
      "reason_for_recall": "Otto Bock Healthcare Products GmbH has identified a design issue through extended durability  testing where the pylon clamping mechanism has the potential to cause damage to the  pylon. When used longer than 1.45 million cycles (which represents approximately 2.3  years of use of the knee joint under heavy usage conditions), AND the pylon clamp is overtightened  according to the labeled torque specification, AND the patient weighs at most  125kg it may be remote that the pylon breaks, and causing the patient to fall.  There have been no failures or complaints reported directly attributed to the failure mode  \u001ccollapsed pylon\u001d.    In the US Market and in Canada, labeling requires a condition based service at three years.  In the rest of the world, a mandatory two year service interval is specified. Only the devices  in distribution in the United States and Canada are affected by this action.",
      "recall_initiation_date": "20170912",
      "center_classification_date": "20180301",
      "termination_date": "20210119",
      "report_date": "20180307",
      "code_info": "Serial Numbers:    201520028, 201520027, 20150026, and 201530040,"
    }
  ]
}