{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "75488",
      "product_res_number": "Z-0537-2010",
      "event_date_initiated": "2008-10-28",
      "event_date_posted": "2009-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-12-10",
      "res_event_number": "50486",
      "product_code": "ISY",
      "product_description": "Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany.\n\nPediatric Prosthetic Device used by Lower Limb amputees.",
      "code_info": "Serial numbers:  200803001, 200803002,  200803003, 200803004, 200803005, 200803006,  200803007, 200803008, and 200803009.",
      "firm_fei_number": "2182293",
      "recalling_firm": "Bock,Otto,Orthopedic Ind,Inc",
      "address_1": "Two Carlson Parkway North, Suite 100 Two Carlson Parkway North",
      "address_2": "Suite 100",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55447",
      "additional_info_contact": "612-553-9464",
      "reason_for_recall": "Otto Bock Health Care LP has discovered that in some cases, the securing screws of the joint axes may not have been properly mounted.  This can cause the axes to gradually move out of the joint and result in a risk of falling for the user.",
      "root_cause_description": "Employee error",
      "action": "Consignees were sent on 10/28/08 a Otto Bock \"Urgent: Correction Notice\"  letter dated October 27, 2008. The letter described the product and problem.  It provided instructions if the product was in stock and instructed the consignee to contact the patients (a patient letter was provided)  and to complete and return the reply card.  Consignees were to contact Otto Bock at their Customer Service to request a return authorization.",
      "product_quantity": "9",
      "distribution_pattern": "The product was only distributed within the US by the US company.  Any OUS distribution was handled by the manufacturer in Germany.",
      "openfda": {
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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"
        ]
      }
    }
  ]
}