{
  "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-2132-2020",
      "product_description": "JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT 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 74035821  SIZE 2, CATALOG NUMBER: REF 74035822  SIZE 3, CATALOG NUMBER: REF 74035823  SIZE 4, CATALOG NUMBER: REF 74035824  SIZE 5, CATALOG NUMBER: REF 74035825  SIZE 6, CATALOG NUMBER: REF 74035826  SIZE 7, CATALOG NUMBER: REF 74035827  SIZE 8, CATALOG NUMBER: REF 74035828  SIZE 9, CATALOG NUMBER: REF 74035829  SIZE 10, CATALOG NUMBER: REF 74035830",
      "product_quantity": "200 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 74035821; LOT/BATCH CODES:  19EM19112R, 19FM05587R, 19FM11174R, 19HM18075, 19HM19648, 19HM21015, 19HM21016, 19HM23242    SIZE 2, CATALOG NUMBER: REF 74035822; LOT/BATCH CODES:  19EM21573R, 19EM21573S, 19FM05589R, 19HM21031, 19HM21033,  19HM21878, 19HM21881    SIZE 3, CATALOG NUMBER: REF 74035823; LOT/BATCH CODES:  19EM21578R, 19HM19009, 19JM09476, 19JM18509, 19JM18525, 19JM21072, 19KM14473, 19KM17780    SIZE 4, CATALOG NUMBER: REF 74035824; LOT/BATCH CODES:  19EM14365R, 19EM14365S, 19FM11173, 19HM18078, 19HM19659, 19HM21861, 19JM21075, 19KM15573, 19KM1557    SIZE 5, CATALOG NUMBER: REF 74035825; LOT/BATCH CODES:  19EM14367R, 19HM18079, 19HM21855, 19KM12683     SIZE 6, CATALOG NUMBER: REF 74035826; LOT/BATCH CODES:  19EM24480R, 19HM18080, 19HM21856, 19KM21512    SIZE 7, CATALOG NUMBER: REF 74035827; LOT/BATCH CODES:  19EM14371R, 19FM01063R, 19FM11177R, 19HM18335, 19HM21873, 19HM21874, 19KM17781    SIZE 8, CATALOG NUMBER: REF 74035828; LOT/BATCH CODES:  19EM24498R, 19EM24498S, 19FM05591R, 19FM11178R, 19FM11178S, 19JM07464, 19JM07465, 19KM07278, 19KM12699    SIZE 9, CATALOG NUMBER: REF 74035829; LOT/BATCH CODES:  19EM21582R, 19FM11179R, 19GM21787, 19JM07467, 19KM07276, 19KM15575, 19KM15576    SIZE 10, CATALOG NUMBER: REF 74035830; LOT/BATCH CODES:  19EM14372R, 19FM11180, 19HM18254, 19JM07468, 19JM07470, 19JM07472, 19KM05610, 19KM15571"
    }
  ]
}