{
  "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": "131333",
      "product_res_number": "Z-0552-2015",
      "event_date_initiated": "2014-09-08",
      "event_date_posted": "2014-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-11-29",
      "res_event_number": "69471",
      "product_code": "HAX",
      "product_description": "Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names",
      "code_info": "1) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Fixation Screw, Springloaded; CareFusion Item Number: NL9513-T; Lot Number: 012412.   2) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion Item Number: NL9515-T; Lot Number: 012412.   3) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Millennium Surgical Item Number: 6-1944LN; Lot Number: 012412.   4) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Boss Instruments Item Number: 74-0181T; Lot Number: 012412.   5) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Stealth Surgical Item Number: SS2195T; Lot Number: 012412.   6) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion Item Number: VM85-12925; Lot Number: 012412.",
      "firm_fei_number": "1421101",
      "recalling_firm": "Instrumed International, Inc.",
      "address_1": "626 Cooper Ct",
      "city": "Schaumburg",
      "state": "IL",
      "postal_code": "60173-4537",
      "additional_info_contact": "Ms. Jennifer S. Staunton\n847-908-6119",
      "reason_for_recall": "The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as \"Pre-Amendment\" devices.",
      "root_cause_description": "No Marketing Application",
      "action": "Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers.  The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.",
      "product_quantity": "49 lock nuts for titanium traction tongs",
      "distribution_pattern": "Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.",
      "openfda": {
        "k_number": [
          "K853066",
          "K842680",
          "K873693",
          "K023959",
          "K930021",
          "K924606",
          "K810193",
          "K980689",
          "K861470",
          "K792586",
          "K915530",
          "K834047",
          "K871663",
          "K954069",
          "K864746",
          "K051918",
          "K003662",
          "K822885",
          "K071173",
          "K090733"
        ],
        "registration_number": [
          "3004464325",
          "2183744",
          "1526439",
          "3008114965",
          "9611274",
          "2182979",
          "8030607",
          "1836161"
        ],
        "fei_number": [
          "3004464325",
          "2183744",
          "1526439",
          "3006509795",
          "3008114965",
          "3002808043",
          "3002750084",
          "2182979"
        ],
        "device_name": "Tong, Skull For Traction",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.5960",
        "device_class": "2"
      }
    }
  ]
}