{
  "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": "122724",
      "product_res_number": "Z-0362-2014",
      "event_date_initiated": "2013-10-24",
      "event_date_posted": "2013-11-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-06-17",
      "res_event_number": "66609",
      "product_code": "ISH",
      "product_description": "Fixed Offset Adapter, A-642100.\r\n\r\nThe Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).",
      "code_info": "Item Number:  A-642100 \t  All Serial Numbers.",
      "firm_fei_number": "1000519909",
      "recalling_firm": "Ossur North America Inc",
      "address_1": "27051 Towne Centre Dr",
      "city": "Foothill Ranch",
      "state": "CA",
      "postal_code": "92610-2804",
      "additional_info_contact": "949-360-3634",
      "reason_for_recall": "Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.",
      "root_cause_description": "Device Design",
      "action": "Ossur sent an \"Safety Notice Voluntary Product Recall\" letter dated October 29, 2013, via regular mail. Follow-up telephones are also made. The letter identified the product the problem and the actions to be taken by the customer.\r\n\r\nssur is committed to providing superior customer service and we will do our utmost to minimize any inconvenience this may cause your practice. To ensure patient safety we kindly ask you to take the following action:\r\n\r\n\" Please identify the users of each of the A-642100 adapters, see attached list.\r\n\" Also, please check your inventory for any A-642100s you may have on hand but have not fitted on users.\r\n\r\n A follow-up phone call will be made a few days later to coordinate replacements.  A new replacement component will be provided to the customer. \r\n\r\nFor further questions please call (949) 360-3634.",
      "product_quantity": "66 units",
      "distribution_pattern": "US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.",
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        "device_name": "Component, External, Limb, Ankle/Foot",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.3420",
        "device_class": "1",
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