{
  "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-1742-2013",
      "product_description": "RemB  Electric Universal Driver REF 6400-099-000  For use with the CORE and TPS System sRx Only    The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM).",
      "product_quantity": "9",
      "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": "0910505713, 1029801073, 1225400823,  1314201603, 1314300713, 1314300723,  1314300733, 1314300743, 1314300753,  1314300763, 1314300773, 1314300783,  1314300793, 1314300803, 1314300813,  1314300823, 1314300833, 1314300843,  1314300853, 1314300863, 1314300873,  1314300883, 1314300893, 1314300903,  1314804033, 1314900053, 1314906453,  1314908193"
    }
  ]
}