{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Memphis",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85110",
      "recalling_firm": "Smith & Nephew, Inc.",
      "address_1": "1450 E Brooks Rd",
      "address_2": "N/A",
      "postal_code": "38116-1804",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide distribution to AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, LA, MA, MI, MN, MS, MT, NC, NJ, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV.      International distribution to Turkey, United Kingdom, Thailand, Switzerland, France, Australia.",
      "recall_number": "Z-1634-2020",
      "product_description": "NAVIO Soft Tissue Protector, included in instrument kits.     The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.",
      "product_quantity": "348 units",
      "reason_for_recall": "Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.",
      "recall_initiation_date": "20200227",
      "center_classification_date": "20200401",
      "termination_date": "20240802",
      "report_date": "20200408",
      "code_info": "Component Product Number: PFSR101092;      a. Instrument Kit Number: PFSR02050, Lot Numbers 2067, 2212, 3809, 3869, 4354, 5228, 5337, 5494, 5514, 5887, 6248;      b. Instrument Kit Number: PFSR02051, Lot Numbers 4354, 5514;      c. Instrument Kit Number: PFSR02052, Lot Numbers 4354, 5494, 6248;      d. Instrument Kit Number: PFSR02053, Lot Numbers 6248"
    }
  ]
}