{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "164124",
      "product_res_number": "Z-2057-2018",
      "event_date_initiated": "2017-12-21",
      "event_date_created": "2018-06-01",
      "recall_status": "Completed",
      "res_event_number": "79978",
      "product_code": "PPR",
      "product_description": "3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box.\n\nThe Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.",
      "code_info": "Lot No. 14239AG2, UPC 07613327055795.  The expiration date marked on the box is August 2018, but it should be August 2016.",
      "firm_fei_number": "2936485",
      "recalling_firm": "Stryker Corporation",
      "address_1": "5900 Optical Ct",
      "city": "San Jose",
      "state": "CA",
      "postal_code": "95138-1400",
      "additional_info_contact": "800-624-4422",
      "reason_for_recall": "Inadvertent shipment of expired units.",
      "root_cause_description": "Incorrect or no expiration date",
      "action": "The firm, Stryker, sent an \"URGENT MEDICAL DEVICE RECALL NOTIFICATION\" letter dated 12/27/2017 to its customers via mail on about 12/28/2017. Customers were initially notified via phone on 12/21/2017 and 12/22/2017. The letter described the product, problem and actions to be taken. The customers were instructed to inform those individuals in the organization who need to be aware of the recall; examine stock for affected devices; quarantine and discontinue use of recalled device; complete and return the Business Reply Form to Stryker Endoscopy via fax (408-855-6314) or email (endorecall@stryker.com), and if affected product is on hand segregate it and contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return and\nissuance of credit or replacement (upon availability).\n\nIf you have any questions, contact Director of Regulatory Affairs and Clinical Science at  408-754-2664 or email: to endorecall@stryker.com.",
      "product_quantity": "2 boxes (5 units per box)",
      "distribution_pattern": "US distribution to Massachusetts only..",
      "openfda": {
        "registration_number": [
          "2032830",
          "3007329020",
          "1643817",
          "1423537",
          "9616088",
          "1061124",
          "3004111573",
          "3009888344"
        ],
        "fei_number": [
          "3001236905",
          "3007329020",
          "3004167986",
          "1643817",
          "1000512168",
          "3004111573",
          "3009888344",
          "3002902735"
        ],
        "device_name": "Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.1100",
        "device_class": "2"
      }
    }
  ]
}