{
  "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": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69785",
      "recalling_firm": "Ebi, Llc",
      "address_1": "399 Jefferson Rd",
      "address_2": "N/A",
      "postal_code": "07054-3707",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.",
      "recall_number": "Z-0909-2015",
      "product_description": "Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws.  Various instruments are also available for use by the surgeon to facilitate implantation of the device.    Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.",
      "product_quantity": "2816 approx.units ( 2688 units US and  128 OUS)",
      "reason_for_recall": "Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.",
      "recall_initiation_date": "20141008",
      "center_classification_date": "20150105",
      "termination_date": "20151221",
      "report_date": "20150114",
      "code_info": "Item Number:  14-571845 5.5 TI 10.5X45MM CANN TRANS  14-571850 5.5 TI 10.5X50MM CANN TRANS  14-571855 5.5 TI 10.5X55MM CANN TRANS  14-571860 5.5 TI 10.5X60MM CANN TRANS  14-571865 5.5 TI 10.5X65MM CANN TRANS  14-571870 5.5 TI 10.5X70MM CANN TRANS  14-571875 5.5 TI 10.5X75MM CANN TRANS  14-571880 5.5 TI 10.5X80MM CANN TRANS  14-571885 5.5 TI 10.5X85MM CANN TRANS  14-571890 5.5 TI 10.5X90MM CANN TRANS  14-571895 5.5 TI 10.5X95MM CANN TRANS  14-571899 5.5 TI 10.5X100MM CANN TRANS",
      "more_code_info": ""
    }
  ]
}