{
  "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": "Broomfield",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70383",
      "recalling_firm": "Biomet Spine, LLC",
      "address_1": "310 Interlocken Pkwy Ste 120",
      "address_2": "N/A",
      "postal_code": "80021-3464",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of:  AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MO, NC, NE, NY, OH, OR, PA, TN, TX, VA, WI. and the countries of: Italy, and Mexico.",
      "recall_number": "Z-1146-2015",
      "product_description": "Set Screw 5.5 mm Rod - Model #7703-1600.   Product Usage:  The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride).    The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.",
      "product_quantity": "1999",
      "reason_for_recall": "Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification",
      "recall_initiation_date": "20121130",
      "center_classification_date": "20150224",
      "termination_date": "20150522",
      "report_date": "20150304",
      "code_info": "LOT Numbers: L561968 and L570545  Product Code: 7703\u00101600",
      "more_code_info": ""
    }
  ]
}