{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "194316",
      "product_res_number": "Z-1366-2022",
      "event_date_initiated": "2022-06-14",
      "event_date_created": "2022-07-12",
      "recall_status": "Open, Classified",
      "res_event_number": "90399",
      "product_code": "QLR",
      "product_description": "Wright EVOLVE TRIAD Plate Cutter, REF 49510120",
      "code_info": "Lot codes:  955401, 1168853, 1349302, 1956936, 2486857",
      "firm_fei_number": "3010667733",
      "recalling_firm": "Wright Medical Technology, Inc.",
      "address_1": "1023 Cherry Rd",
      "city": "Memphis",
      "state": "TN",
      "postal_code": "38117-5423",
      "additional_info_contact": "Meghan Wells\n901-201-9298",
      "reason_for_recall": "The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use",
      "root_cause_description": "Device Design",
      "action": "The firm sent an URGENT MEDICAL DEVICE RECALL notice on beginning 06/14/2022 by letter (FedEx).  The letter discussed the issue and potential risk, an requested the following actions be taken:  \n\"1.\tImmediately check your internal inventory to locate the product listed on the attached business reply form and remove them from their point of use.\n2.\tReturn the enclosed business reply form by email to confirm receipt of this notification/document product segregation.\na.\tResponse is required, even if you may not have any physical inventory on site anymore. It may be that you no longer have any physical inventory on site.  Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter.  Therefore, please complete even if you no longer have any of the subject devices in your physical inventory.\n3.\tUpon receipt of the completed business reply form, Stryker will contact you to arrange for the return of your product(s).\n4.\tMaintain awareness of this communication internally until all required actions have been completed within your facility.\n5.\tIf you have further distributed the affected product, please notify the applicable parties at once about this recall.  You may copy and distribute this notification letter. \na.\tIf possible, inform us if any of the subject devices have been distributed to other organizations. Including contact details so that we can inform the recipients appropriately.\nb.\tIf you are a distributor, note that you are responsible for notifying your affected customers. \n6.\tPlease inform us of any adverse event and/or report them to the Health/Competent Authorities in accordance with current regulations.\"",
      "product_quantity": "231",
      "distribution_pattern": "Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico",
      "openfda": {
        "k_number": [
          "K253118"
        ],
        "registration_number": [
          "3009973336",
          "1835444",
          "3025435185"
        ],
        "fei_number": [
          "3009973336",
          "3025435185",
          "3000717687"
        ],
        "device_name": "Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.4520",
        "device_class": "2"
      }
    }
  ]
}