{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215366",
      "product_res_number": "Z-2516-2025",
      "event_date_initiated": "2025-07-16",
      "event_date_posted": "2025-09-04",
      "recall_status": "Open, Classified",
      "res_event_number": "97367",
      "product_code": "QWK",
      "pma_numbers": [
        "P220002"
      ],
      "product_description": "TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.",
      "code_info": "Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.",
      "firm_fei_number": "3012401682",
      "recalling_firm": "PREMIA SPINE LTD",
      "address_1": "Giborey Israel 7",
      "city": "Netanya",
      "state": "Ramat Poleg",
      "country": "Israel",
      "reason_for_recall": "Potential for missing pins at tip of inserter.",
      "root_cause_description": "Process change control",
      "action": "On 07/16/2025, Premia Spine Ltd. notified Premia Spine Inc. via phone call. It was requested to quarantine any suspected reworked instruments that are at the warehouse and to initiate a field action and return the affected units of the TOPS Inserter that underwent rework. \n\n No customers (hospitals/physicians) were asked to quarantine or return units as all affected units were within Premia Spine's control, however one surgeon was notified, on about 07/31/2025, of the issue and was requested to review the surgical procedure, analyze relevant  patient data, including x-ray, and perform additional actions if needed to confirm the pin has not remained in the patient's body.",
      "product_quantity": "30 units",
      "distribution_pattern": "US Nationwide distribution in the state of Connecticut.",
      "openfda": {
        "pma_number": [
          "P220002"
        ],
        "registration_number": [
          "3002808227",
          "3006984710",
          "1319660",
          "9612277",
          "9611827",
          "3012401682"
        ],
        "fei_number": [
          "1000136478",
          "3002808227",
          "3002807421",
          "3006984710",
          "3002807328",
          "3012401682"
        ],
        "device_name": "Prosthesis, Posterior Spinal Elements",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}