{
  "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",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "148779",
      "product_res_number": "Z-0120-2017",
      "event_date_initiated": "2016-08-11",
      "event_date_posted": "2016-10-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-04-27",
      "res_event_number": "74918",
      "product_code": "HQE",
      "k_numbers": [
        "K121675"
      ],
      "product_description": "25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.",
      "code_info": "Lot number M548370 (1 each or box of 6 each), exp 11/2018 Lot number M578150 (1 each or box of 6 each), exp 02/2019",
      "firm_fei_number": "1000119053",
      "recalling_firm": "Synergetics Inc",
      "address_1": "3845 Corporate Centre Dr",
      "city": "O Fallon",
      "state": "MO",
      "postal_code": "63368-8678",
      "additional_info_contact": "Steve Puljak\n314-939-5100",
      "reason_for_recall": "Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.",
      "root_cause_description": "Other",
      "action": "A customer notification letter was sent out on 8/11/2016 to the hospital/surgical center level.  Customers were asked to fill out and return a recall acknowledgment form and send back any affected devices.",
      "product_quantity": "72 units",
      "distribution_pattern": "Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT.  Foreign distribution to the UK, France, Mexico, and India.",
      "openfda": {
        "k_number": [
          "K854868",
          "K920582",
          "K890300",
          "K834437",
          "K812857",
          "K844374",
          "K954816",
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          "K881927",
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          "K970673",
          "K970670",
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          "K914221",
          "K896943",
          "K820026",
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          "K880968",
          "K212763",
          "K940746",
          "K771711",
          "K834163",
          "K953576",
          "K946135",
          "K922355",
          "K913837",
          "K924604",
          "K791212",
          "K862188",
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          "K020911",
          "K830216",
          "K120170",
          "K854871",
          "K842793",
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          "K953575",
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          "K896754",
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          "K933208",
          "K864035",
          "K842471",
          "K890622",
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          "K170183",
          "K992943",
          "K853961",
          "K853308",
          "K121675",
          "K980399",
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          "K820933",
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          "K844715",
          "K880929",
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          "K964743",
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          "K891601",
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          "K896305",
          "K881519",
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          "K884557",
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          "K813274",
          "K854508",
          "K842197",
          "K781471",
          "K884043",
          "K834160",
          "K883975",
          "K885196",
          "K960061",
          "K860014",
          "K842188",
          "K904909",
          "K834155",
          "K913504",
          "K894278",
          "K961078",
          "K834162",
          "K912384",
          "K934600",
          "K950799",
          "K851610"
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        "registration_number": [
          "3010291427",
          "2028159",
          "1722139",
          "1650907",
          "3005012805",
          "3019924",
          "9681121",
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          "1526711",
          "3003398873",
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          "3010208880",
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        "fei_number": [
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          "3005012805",
          "1000125147",
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          "3002681132",
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          "3006946276",
          "1526711",
          "3003398873",
          "3006003617",
          "1000119053",
          "3010208880"
        ],
        "device_name": "Instrument, Vitreous Aspiration And Cutting, Ac-Powered",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4150",
        "device_class": "2"
      }
    }
  ]
}