{
  "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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  "results": [
    {
      "cfres_id": "94039",
      "product_res_number": "Z-0059-2011",
      "event_date_initiated": "2010-08-02",
      "event_date_posted": "2010-10-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-08-20",
      "res_event_number": "56589",
      "product_code": "HXO",
      "product_description": "Closed knot pusher REF 902813,  Biomet Sports Medicine, Warsaw, IN.\nThe device is intended to push knots down a limb of suture.",
      "code_info": "098750, 278290, 538080, 666270, 864100 and 948870.",
      "firm_fei_number": "1825034",
      "recalling_firm": "Biomet, Inc.",
      "address_1": "56 E Bell Dr",
      "city": "Warsaw",
      "state": "IN",
      "postal_code": "46582-6989",
      "additional_info_contact": "Mary Johnson\n574-267-6639 Ext. 1676",
      "reason_for_recall": "The firm has received four complaints that  the closed knot pusher is missing a radius which contributes to sutures being cut during surgery.",
      "root_cause_description": "Device Design",
      "action": "Biomet Sports Medicine sent URGENT MEDICAL DEVICE RECALL NOTICES  dated 8/2/2010 to its customers and distributors.  The notices stated that the use of the device should be discontinued and the products returned to Biomet.\nHealthcare professionals and consumers were to report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online at www.fda.gov/MedWatch/report.htm, by regular mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or by phone at (800)FDA-1088 or Fax (800)FDA-0178.\nQuestions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8AM to 5PM.",
      "product_quantity": "101",
      "distribution_pattern": "Worldwide Distribution - USA, including FL, NY, VA, CA, GA, AL, PA, MI, LA, KS, SD, KY, TX, AR, and WV, and the countries of Belgium, Italy, Argentina, Poland, Netherlands, Turkey and Portugal.",
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        "device_name": "Pusher, Socket",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.4540",
        "device_class": "1"
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}