{
  "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": "2026-08-15",
    "results": {
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  "results": [
    {
      "cfres_id": "196583",
      "product_res_number": "Z-0240-2023",
      "event_date_initiated": "2022-10-21",
      "event_date_posted": "2022-11-15",
      "recall_status": "Open, Classified",
      "res_event_number": "91044",
      "product_code": "MBB",
      "k_numbers": [
        "K123081"
      ],
      "product_description": "Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin\nCatalog Number: 6193-1-010",
      "code_info": "UDI: (01)14260056885768(17)231130(10)145BB909GC\nLot Number: 202BB943KC\nExp. Date: 30/Sep/2024",
      "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": "Bradley Curtis\n201-831-5000",
      "reason_for_recall": "Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010)  were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)",
      "root_cause_description": "Under Investigation by firm",
      "action": "Stryker issued an An Urgent Medical Device Recall (UMDR)   PFA 3082664 Letter issued by Sedgewick on 21/Oct/2022, via UPS 2-day air. Letter states reason for recall, health risk and action to take:\n1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware within your organization.\n2. Immediately check all stock areas and/or operating room storage to determine if the device from the affected product table is at your facility.\n3. Quarantine and discontinue use of the recalled device identified in the affected product table.\n4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email: strykerortho5780@sedgwick.com\nFax: (888)-912-7352\n5. Please return the devices back to Stryker using the following address:\nStryker Orthopaedics/PFA Product Returns\nAttn: Distribution Inventory Team\n325 Corporate Drive\nDock M-East\nMahwah, NJ 07430\nRef. PFA 3082664\n6. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement, returns and inventory questions.\nPlease assist us in meeting our regulatory obligation by emailing back the attached Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site.\n\nIf you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com",
      "product_quantity": "90 units",
      "distribution_pattern": "US Nationwide distribution.",
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        "device_name": "Bone Cement, Antibiotic",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3027",
        "device_class": "2",
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