{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Allendale",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63386",
      "recalling_firm": "Stryker Spine",
      "address_1": "2 Pearl Ct",
      "address_2": "N/A",
      "postal_code": "07401-1611",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.",
      "recall_number": "Z-0382-2013",
      "product_description": "SPECIALTY AUDIBLE TORQUE WRENCH, XIA    IS2217XLP      MFG BY: STRYKER SPINE  2 PEARL COURT  ALLENDALE NJ 07401-1677    The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible \"click\" when the desired final tightening torque is reached.",
      "product_quantity": "28 units",
      "reason_for_recall": "Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.",
      "recall_initiation_date": "20120809",
      "center_classification_date": "20121119",
      "termination_date": "20150930",
      "report_date": "20121128",
      "code_info": "Class I device, 510(K) exempt    Catalog Number: IS2217XLP  Lot Number: 2576, 2756"
    }
  ]
}