{
  "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": "85433",
      "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": "E-Mail",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-2133-2020",
      "product_description": "JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable spikes (spike rail) aids in provisional fixation of the trial.  SIZE 1, CATALOG NUMBER: REF 74035831  SIZE 2, CATALOG NUMBER: REF 74035832  SIZE 3, CATALOG NUMBER: REF 74035833  SIZE 4, CATALOG NUMBER: REF 74035834  SIZE 5, CATALOG NUMBER: REF 74035835  SIZE 6, CATALOG NUMBER: REF 74035836  SIZE 7, CATALOG NUMBER: REF 74035837  SIZE 8, CATALOG NUMBER: REF 74035838  SIZE 9, CATALOG NUMBER: REF 74035839  SIZE 10, CATALOG NUMBER: REF 74035840",
      "product_quantity": "195 units",
      "reason_for_recall": "The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.",
      "recall_initiation_date": "20200128",
      "center_classification_date": "20200527",
      "termination_date": "20231211",
      "report_date": "20200603",
      "code_info": "SIZE 1, CATALOG NUMBER: REF 74035831; LOT/BATCH CODES:  19FM01064R, 19HM18082, 19HM21871, 19JM18534, 19JM21086, 19KM07281, 19KM15577    SIZE 2, CATALOG NUMBER: REF 74035832; LOT/BATCH CODES:  19EM21587R, 19FM11181R, 19HM21899, 19HM21902, 19HM21903, 19JM21089    SIZE 3, CATALOG NUMBER: REF 74035833; LOT/BATCH CODES:  19GM21768, 19HM18085, 19HM18085A, 19JM09477, 19JM18537, 19JM18540, 19JM18541, 19JM18542, 19JM18542A    SIZE 4, CATALOG NUMBER: REF 74035834; LOT/BATCH CODES:  19FM11183R, 19JM07474, 19JM11137, 19JM21090, 19KM21513    SIZE 5, CATALOG NUMBER: REF 74035835; LOT/BATCH CODES:  19FM01065R, 19HM18086, 19HM18086A, 19HM18088, 19JM18491,  19JM21091, 19KM15580    SIZE 6, CATALOG NUMBER: REF 74035836; LOT/BATCH CODES:  19FM11184R, 19GM21778, 19JM07477, 19JM21093    SIZE 7, CATALOG NUMBER: REF 74035837; LOT/BATCH CODES:  19FM11185A, 19FM11185R, 19HM19006, 19JM21096, 19KM21504, 19KM21506, 19KM21509    SIZE 8, CATALOG NUMBER: REF 74035838; LOT/BATCH CODES: 19FM11191R, 19FM11191S, 19HM18091, 19HM21040, 19JM18543, 19JM21097, 19JM23714, 19KM15583     SIZE 9, CATALOG NUMBER: REF 74035839; LOT/BATCH CODES:  19FM05578R, 19HM18096, 19HM19658, 19KM05613, 19KM15584, 19KM15586    SIZE 10, CATALOG NUMBER: REF 74035840; LOT/BATCH CODES:  19HM18107, 19HM19004, 19JM23666, 19JM23674, 19JM23678, 19JM23678A, 19JM23680, 19KM12708"
    }
  ]
}