{
  "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",
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      "cfres_id": "42906",
      "product_res_number": "Z-0388-06",
      "event_date_initiated": "2005-10-21",
      "event_date_posted": "2006-01-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-03-20",
      "res_event_number": "34013",
      "product_code": "ISH",
      "product_description": "Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.",
      "code_info": "Serial Numbers: 5927, 5930, 5935, 5936, 5937, 5938, 5939, 5940, 5941, 5942, 5943, 5944, 5945, 5947, 5948, 5949, 5950, 5951, 5954, 5955, 5956, 5959, 5960, 5961, 5962, 5964, 5965, 5970, 5971, 5972, 5973, 5974, 5975, 5977, 5978, 5979, 5980, 6015, 6016, 6020, 6027, 6028, 6031, 6032.",
      "firm_fei_number": "3003764610",
      "recalling_firm": "Ossur",
      "address_1": "Grjothals 5 5 grjothals",
      "city": "Reykjavik",
      "country": "Ireland",
      "additional_info_contact": "Johanna Valdimarsdottir\n354-515-1300",
      "reason_for_recall": "After one year devices assembled with a new type of O-rings could exhibit enough wear to allow a gradual oil leak which would increase play in the ankle sub-assembly of the foot.",
      "root_cause_description": "Other",
      "action": "Telephone communication followed by notification letter mailed to end users (patients) and prosthetics workshops. A pre-paid package to return faulty components to Ossur included with mailed letters. New replacement feet will be shipped to customers.",
      "product_quantity": "48 (23 in US)",
      "distribution_pattern": "Nationwide",
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        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.3420",
        "device_class": "1",
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