{
  "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": "Plainsboro",
      "address_1": "311 Enterprise Dr",
      "reason_for_recall": "Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter.  This could potentially result in the lordosis of the rod not aligning with the handle when the inserter is used in accordance with the current NewPort MIS System Surgical Technique.",
      "address_2": "",
      "product_quantity": "94 units",
      "code_info": "Lot No.    Z21781A (45mm NewPort MIS Rod, 2)  Z21956A (50mm NewPort MIS Rod, 2)  Z21782A (55mm NewPort MIS Rod, 2)  Z21957A (60mm NewPort MIS Rod, 2)  Z21784A (75mm NewPort MIS Rod, 2)  Z21958A (80mm NewPort MIS Rod, 2)",
      "center_classification_date": "20140701",
      "distribution_pattern": "Worldwide Distribution.  US including states of CA, FL, IL, MD, MO, TN, TX, and countries of Australia, Czech Republic and Spain.",
      "state": "NJ",
      "product_description": "MIS Rod 2, a component of the NewPort System.    Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm).  The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws",
      "report_date": "20140709",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Integra LifeSciences Corp.",
      "recall_number": "Z-1961-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68498",
      "termination_date": "20141106",
      "more_code_info": "",
      "recall_initiation_date": "20140609",
      "postal_code": "08536-3344",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}