{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "142592",
      "product_res_number": "Z-0608-2016",
      "event_date_initiated": "2016-01-04",
      "event_date_created": "2016-02-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-05-02",
      "res_event_number": "72960",
      "product_code": "ISY",
      "product_description": "Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD.  Used for the prosthetic fitting of amputations of the lower. limb.",
      "code_info": "All serviced between 27 April 2015 and 17 November 2015",
      "firm_fei_number": "3003117657",
      "recalling_firm": "Otto Bock Healthcare GmbH",
      "address_1": "Max-Nader-Str. #15 #15 max-nader-str.",
      "city": "Duderstadt",
      "country": "Germany",
      "additional_info_contact": "Lex J. Pearce\n801-971-6618",
      "reason_for_recall": "Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Loctite was\nused during repair.",
      "root_cause_description": "Process control",
      "action": "Starting Jan 4 2016, In coordination with the Manufacturer, the US Agent will notify customers via telephone call of the correction on behalf of the Manufacturer. The customers will be requested to return the affected devices back to the service center for correction. The devices will be returned to the customer following correction.",
      "product_quantity": "40 units",
      "distribution_pattern": "Nationwide Distribution.",
      "openfda": {
        "registration_number": [
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        "fei_number": [
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          "3009340798",
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          "1000220701",
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        ],
        "device_name": "Joint, Knee, External Limb Component",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.3420",
        "device_class": "1",
        "k_number": [
          "K101859"
        ]
      }
    }
  ]
}