{
  "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,
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  "results": [
    {
      "cfres_id": "114783",
      "product_res_number": "Z-0783-2013",
      "event_date_initiated": "2012-09-05",
      "event_date_posted": "2013-02-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-08-13",
      "res_event_number": "63793",
      "product_code": "HTT",
      "product_description": "Anspach Effort, Inc.,  98-0061 MA-15C  Bearing Sleeve with Removable Bur Guard.  A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.",
      "code_info": "Lot number: 2000930",
      "firm_fei_number": "1045834",
      "recalling_firm": "The Anspach Effort, Inc.",
      "address_1": "4500 Riverside Drive",
      "city": "Palm Beach Gardens",
      "state": "FL",
      "postal_code": "33410-4235",
      "additional_info_contact": "Jessica Smith\n561-627-1080",
      "reason_for_recall": "Contact\r\nbetween the bur and bur guard could generate metal fragments that may or may not be visible to the\r\nsurgeon and can potentially remain in the surgical site.   \r\nThe materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm, Anspach Effort, Inc. sent an \"URGENT: Medical Device Removal\" letter dated November 7, 2012, to its customer. The letter identified the product, problem and actions to be taken. \r\n\r\nThe customer was instructed to do the following: 1) Screen their inventory and remove and return all products immediately. 2) Complete and return the attached Customer Reply Form via fax or email to the address provided on the form. \r\n\r\nShould the customer have any questions, please contact  Anspach Product Support at (800) 327-6887.",
      "product_quantity": "8 devices",
      "distribution_pattern": "Distributed in the state of Massachusetts",
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        "device_name": "Burr, Orthopedic",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.4540",
        "device_class": "1"
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}