{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Warsaw",
      "address_1": "56 E Bell Dr",
      "reason_for_recall": "Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.",
      "address_2": "",
      "product_quantity": "",
      "code_info": "The kits that include the TunneLoc products, ACL in a box, PNs 906532, 906533, 906534, and 906535 are packed in a box alongside the Instructions for use and is distributed  non-sterile .",
      "center_classification_date": "20180315",
      "distribution_pattern": "US Nationwide Distribution",
      "state": "IN",
      "product_description": "TunneLoc Tibial Fixation Device (Within an ACL Kit)    Product Usage:  To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.",
      "report_date": "20180321",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Zimmer Biomet, Inc.",
      "recall_number": "Z-1072-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79263",
      "termination_date": "20200507",
      "more_code_info": "",
      "recall_initiation_date": "20171011",
      "postal_code": "46582-6989",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}