{
  "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": "122358",
      "product_res_number": "Z-0410-2014",
      "event_date_initiated": "2013-07-30",
      "event_date_posted": "2013-11-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-04-16",
      "res_event_number": "66414",
      "product_code": "OAR",
      "product_description": "Vertebroplasty Needle Kit 10g Diamond Tip \r\n\r\nIntended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.",
      "code_info": "Part No. 03.702.218S, Lot No. AJM838X",
      "firm_fei_number": "3005180112",
      "recalling_firm": "Synthes USA HQ, Inc.",
      "address_1": "1302 Wrights Ln E",
      "city": "West Chester",
      "state": "PA",
      "postal_code": "19380-3417",
      "additional_info_contact": "Customer Support\n610-719-5000",
      "reason_for_recall": "Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.",
      "root_cause_description": "Incorrect or no expiration date",
      "action": "Synthes sent an Urgent Notice:  Medical Device Notification letter dated October 8, 2013, to all affected customers.   The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number.  Return the Verification Form to:\r\nCredit/Returns\r\nSynthes\r\n1101 Synthes Avenue\r\nMonument, CO  80132\r\nCustomers were also instructed to return the Verification Section even if they don't have the affected product.  \r\nCustomers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant.\r\nFor questions regarding this recall call 610-719-5000.",
      "product_quantity": "40",
      "distribution_pattern": "Nationwide Distribution including IN, MT, HI, and FL.",
      "openfda": {
        "device_name": "Injector, Vertebroplasty (Does Not Contain Cement)",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.4200",
        "device_class": "1",
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        "k_number": [
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}