{
  "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
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  },
  "results": [
    {
      "cfres_id": "131421",
      "product_res_number": "Z-0813-2015",
      "event_date_initiated": "2014-11-06",
      "event_date_posted": "2014-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-08-21",
      "res_event_number": "69719",
      "product_code": "KWD",
      "k_numbers": [
        "K060560"
      ],
      "product_description": "Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents.  Size 10; Catalogue No. PCS-430-10-WW",
      "code_info": "Lot numbers: 140098T and 140929T",
      "firm_fei_number": "3003418325",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "311 Enterprise Dr",
      "city": "Plainsboro",
      "state": "NJ",
      "postal_code": "08536-3344",
      "additional_info_contact": "David E. Gronostajski\n609-936-6822",
      "reason_for_recall": "Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm sent out written notification of the recall on 11/6/14.  The letter instructed the consignees to quarantine and return any affected product.",
      "product_quantity": "19 units",
      "distribution_pattern": "WA, Australia, and France",
      "openfda": {
        "k_number": [
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          "K060536",
          "K023770",
          "K030319",
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        "device_name": "Prosthesis, Toe, Hemi-, Phalangeal",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3730",
        "device_class": "2",
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