{
  "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": {
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      "cfres_id": "143494",
      "product_res_number": "Z-0872-2016",
      "event_date_initiated": "2016-01-21",
      "event_date_posted": "2016-02-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-06-08",
      "res_event_number": "73156",
      "product_code": "MAY",
      "product_description": "Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm\n\nProduct Usage:\nIntended for the temporary stabilization of bone segments or fragments.",
      "code_info": "Catalog number 1320-0016S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",
      "firm_fei_number": "3003070421",
      "recalling_firm": "Stryker Howmedica Osteonics Corp.",
      "address_1": "325 Corporate Dr",
      "city": "Mahwah",
      "state": "NJ",
      "postal_code": "07430-2006",
      "additional_info_contact": "Mr. Eric Petschler\n201-831-5000",
      "reason_for_recall": "During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Stryker Orthopaedics sent an Urgent Medical Device Removal letter and Customer Response forms dated January 21, 2016 through UPS.  The letter identified the affected product, problem, actions to be taken including forwarding notice if applicable, returning all affected products and completing and returning the Customer Response form to Stericycle.by the instructions provided.",
      "product_quantity": "147,838 units in total",
      "distribution_pattern": "US Nationwide Distribution",
      "openfda": {
        "k_number": [
          "K051844",
          "K123604",
          "K090103",
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        "device_name": "Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3353",
        "device_class": "2"
      }
    }
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}