{
  "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,
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    }
  },
  "results": [
    {
      "cfres_id": "161326",
      "product_res_number": "Z-0623-2018",
      "event_date_initiated": "2017-09-01",
      "event_date_posted": "2018-02-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-04-03",
      "res_event_number": "79092",
      "product_code": "HBB",
      "product_description": "The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.",
      "code_info": "ELAN 4 Air System \tST0607 ELAN 4 Air Control Set \tST0608 ELAN 4 Air Neuro Crani Set \tST0609 ELAN 4 Air Spine Set \tST06411 ELAN 4 Air HD Spine Set \tST0614 ELAN 4 Air Micro Saw Set \tST0615 ELAN 4 Air Hand Control Set \tST0638 ELAN 4 Air Large Saw Set",
      "firm_fei_number": "2916714",
      "recalling_firm": "Aesculap Implant Systems LLC",
      "address_1": "3773 Corporate Pkwy",
      "city": "Center Valley",
      "state": "PA",
      "postal_code": "18034-8217",
      "additional_info_contact": "800-258-1946",
      "reason_for_recall": "The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance.   This issue does not affected sales outside the United States (OUS).",
      "root_cause_description": "No Marketing Application",
      "action": "On September 1, 2017 an Urgent Medical Device Recall letter was issued to customers for the ELAN 4 Air System which includes the following sub-components:\nST0607 ELAN 4 Air Control Set\n\tST0608 ELAN 4 Air Neuro Crani Set\n\tST0609 ELAN 4 Air Spine Set\n\tST06411 ELAN 4 Air HD Spine Set\n\tST0614 ELAN 4 Air Micro Saw Set\n\tST0615 ELAN 4 Air Hand Control Set\n\tST0638 ELAN 4 Air Large Saw Set\n\nThe letter directs customers to take the following actions:\n1.\tReview the Voluntary Urgent Medical Device Recall Notification Letter in its entirety and ensure that all users in your organization and other concerned persons are informed about this recall and immediately discontinue use.  \n\n2.\tDetermine your current inventory of affected products within your facility. Immediately remove the affected products and return to Aesculap Inc. Do not destroy any affected products. \n\t\n3.\tUtilizing the attached Product Recall Acknowledgement Response Form on the next page of this letter, record the total number of products in your possession.  If you have no inventory remaining, please enter zero (0) on the form and a REASON WHY (example, returned evaluation system to sales representative). \n\n4.\tPlease contact Customer Service and they will provide you with a Returned Goods number and return label.\n\n\tCustomer Service:  \t1-800-282-9000\n\t\t\t\taesculap_emailorders.bbmus_service@bbraun.com",
      "product_quantity": "167 Units",
      "distribution_pattern": "Nationwide Distribution.",
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          "K150801",
          "K013091",
          "K972289",
          "K895739",
          "K093361",
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        ],
        "registration_number": [
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        "fei_number": [
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          "3015453963",
          "3004598644",
          "1000219637",
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          "1000517638",
          "1000512168",
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          "3040335671",
          "3002807310",
          "1000306340",
          "3000270450",
          "3014279513",
          "2647346"
        ],
        "device_name": "Motor, Drill, Pneumatic",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4370",
        "device_class": "2"
      }
    }
  ]
}