{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Schaumburg",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69471",
      "recalling_firm": "Instrumed International, Inc.",
      "address_1": "626 Cooper Ct",
      "address_2": "N/A",
      "postal_code": "60173-4537",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.",
      "recall_number": "Z-0554-2015",
      "product_description": "Traction tong replacement screws, non-springloaded 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, Boss Instruments, and Stealth Surgical brand names.",
      "product_quantity": "17 traction tong replacement screws, non-springloaded",
      "reason_for_recall": "The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.",
      "recall_initiation_date": "20140908",
      "center_classification_date": "20141208",
      "termination_date": "20171129",
      "report_date": "20141217",
      "code_info": "1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Fixation Screw Non-Springloaded; CareFusion Item Number: NL9514-T; Lot Number: 100512.     2) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: Boss Instruments; Boss Instruments Product Name: Replacement Screw Non-Springloaded, Traction Tong; Boss Instruments Item Number: 74-0185T; Lot Numbers: 020512, 100512, 110211.     3) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Stealth Surgical Item Number: SS2193BT; Lot Numbers: 070312.     4) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: CareFusion; CareFusion Product Name: Replacement Screw Non-Springloaded, Traction Tong; CareFusion Item Number: VM85-12965; Lot Numbers: 100512, 110211."
    }
  ]
}