{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "192264",
      "product_res_number": "Z-0864-2022",
      "event_date_initiated": "2022-02-25",
      "event_date_created": "2022-04-04",
      "recall_status": "Open, Classified",
      "res_event_number": "89671",
      "product_code": "OJH",
      "product_description": "Total Knee Pack - Surgical Kit",
      "code_info": "SKU/Part Number 570-2676; UDI H65257026760\n\nLot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064",
      "firm_fei_number": "1000111025",
      "recalling_firm": "Stradis Medical, LLC dba Stradis Healthcare",
      "address_1": "3025 Northwoods Pkwy",
      "city": "Peachtree Corners",
      "state": "GA",
      "postal_code": "30071-1524",
      "additional_info_contact": "Kristy Wynn\n470-330-2909",
      "reason_for_recall": "The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.",
      "root_cause_description": "Process change control",
      "action": "A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.",
      "product_quantity": "76 units",
      "distribution_pattern": "US Nationwide distribution in the states of IN, TX, and PA.",
      "openfda": {
        "device_name": "Orthopedic Tray",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4800",
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