{
  "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": "Portage",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65456",
      "recalling_firm": "Stryker Instruments Div. of Stryker Corporation",
      "address_1": "4100 E Milham Ave",
      "address_2": "N/A",
      "postal_code": "49002-9704",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.",
      "recall_number": "Z-1741-2013",
      "product_description": "CORE Universal Driver REF 5400- 99 Rx Only    This drill may also be used with theTotal Performance System (TPS\").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.",
      "product_quantity": "11",
      "reason_for_recall": "The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software.  Handpieces that have been programmed with the incorrect parameters could result in unintended activation.  There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100",
      "recall_initiation_date": "20130701",
      "center_classification_date": "20130716",
      "termination_date": "20130916",
      "report_date": "20130724",
      "code_info": "Serial Number 0326801633, 0330802913, 0406200763, 0410401383, 0410600013, 0534203093,0627600783, 0730101013, 0730101033,  0805000553, 0809829593, 0935603083,1011903103, 1011903493, 1013814003, 1025400463, 1025400643, 1126901343, and  1128022593"
    }
  ]
}