{
  "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": "2026-08-13",
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    {
      "cfres_id": "190228",
      "product_res_number": "Z-0313-2022",
      "event_date_initiated": "2021-10-15",
      "event_date_created": "2021-11-30",
      "recall_status": "Open, Classified",
      "res_event_number": "88964",
      "product_code": "JDG",
      "k_numbers": [
        "K173499"
      ],
      "product_description": "28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028",
      "code_info": "UDI number - (01) 07613327012996(17)261913(10);\nlot numbers - 86953401, 86953503",
      "firm_fei_number": "3003070421",
      "recalling_firm": "Howmedica Osteonics Corp.",
      "address_1": "325 Corporate Dr",
      "city": "Mahwah",
      "state": "NJ",
      "postal_code": "07430-2006",
      "additional_info_contact": "Rehad Gaffoor\n201-831-5000",
      "reason_for_recall": "XXX",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 10/15/2021, Stryker issued Urgent Medical Device Recall notices to customers.  \n\nActions Needed:\n1.\tPlease inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware.\n2.\tImmediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility.\n3.\tQuarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. \n4.\tHospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form\n5.\tHospitals Only:  Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions.\n6.\tPlease forward this Urgent Medical Device Recall to the individuals or organizations who have consigned product, if applicable. Return all affected devices available at your location to the following address.\n\nStryker Orthopaedics/PFA Product Returns\nAttn: Distribution Inventory Team\n325 Corporate Drive\nDock M-East\nMahwah, NJ  07430\nRef. PFA 2812588",
      "distribution_pattern": "Puerto Rico",
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        "device_name": "Prosthesis, Hip, Femoral Component, Cemented, Metal",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3360",
        "device_class": "2"
      }
    }
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