{
  "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": [
    {
      "country": "United States",
      "city": "Parsippany",
      "address_1": "100 Interpace Pkwy",
      "reason_for_recall": "Polaris Translation Screw Failures were recently reported to Biomet Spine.  These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.",
      "address_2": "",
      "product_quantity": "7,092 units",
      "code_info": "Multiple Item and Lot numbers.  The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the   SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.",
      "center_classification_date": "20131119",
      "distribution_pattern": "Nationwide distribution including Puerto Rico.",
      "state": "NJ",
      "product_description": "BIOMET Spine,  5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only.  Non-Sterile.    Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system",
      "report_date": "20131127",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ebi, Llc",
      "recall_number": "Z-0359-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66300",
      "termination_date": "20160831",
      "more_code_info": "",
      "recall_initiation_date": "20130822",
      "postal_code": "07054-1149",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}