{
  "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": "Carlsbad",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63385",
      "recalling_firm": "Alphatec Spine, Inc.",
      "address_1": "5818 El Camino Real",
      "address_2": "N/A",
      "postal_code": "92008-8816",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including  AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and  UT.",
      "recall_number": "Z-0168-2013",
      "product_description": "ILLlCO¿ MIS Posterior Fixation System,  Bone-screw Internal Spinal Fixation System,  Orthosis, Spinal Pedical Fixation  Orthosis, Spondylolisthesis Spinal Fixation      The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. When used for a minimally invasive posterior approach ILLlCO¿ MIS Instrumentation is used in conjunction with polyaxial screw components. The ILLICO MIS Posterior Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the ILLICO MIS Posterior Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.",
      "product_quantity": "209 screws",
      "reason_for_recall": "The firm initiated the recall because the stainless steel guide-wire of the  Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti  Cannulated Polyaxial Screws, therefore rendering such screws nonfunctional.",
      "recall_initiation_date": "20120925",
      "center_classification_date": "20121029",
      "termination_date": "20130329",
      "report_date": "20121107",
      "code_info": "Product Codes: KW, MNI, MNH.    Part NumberlLot Number:  ¿PART DESCRIPTION LOT     7384S-30  Ti CANNULATED POLYAXIAL SCREW 4.5mm X 30mm  646501      73845-35  Ti CANNULATED POLYAXIAL SCREW 4.5mm X 35mm  646502     73845-40  Ti CANNULATED POLYAXIAL SCREW 4.5mm X 40mm  646503     73845-45  Ti CANNULATED POLYAXIAL SCREW 4.5mm X 45mm  646504     73855-35  Ti CANNULATED POLYAXIAL SCREW 5.5mm X 35mm  646510     73865-30  Ti CANNULATED POLYAXIAL SCREW 6.5mm X 30mm  646515     73865-35  Ti CANNULATED POLYAXIAL SCREW 6.5mm X 35mm  646516     73865-40  Ti CANNULATED POLYAXIAL SCREW 6.5mm X 40mm  646517     73865-45  Ti CANNULATED POLYAXIAL SCREW 6.5mm X 45mm  646542     73865-50  Ti CANNULATED POLYAXIAL SCREW 6.5mm X 50mm  646543     73875-35  Ti CANNULATED POLYAXIAL SCREW 7.5mm X 35mm  646546     73875-45  Ti CANNULATED POLYAXIAL SCREW 7.5mm X 45mm  646548     73875-50  Ti CANNULATED POLYAXIAL SCREW 7.5mm X 50mm  646549",
      "more_code_info": ""
    }
  ]
}