{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85613",
      "recalling_firm": "Zimmer Biomet, Inc.",
      "address_1": "1800 W Center St",
      "address_2": "N/A",
      "postal_code": "46580-2304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US nationwide distribution.",
      "recall_number": "Z-2219-2020",
      "product_description": "Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number 810M6535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.",
      "product_quantity": "3235 total",
      "reason_for_recall": "There are reports of inadequate locking of the extended tab screws.  Complaints were reported where the closure top backed out of the screw post-operatively.",
      "recall_initiation_date": "20200505",
      "center_classification_date": "20200602",
      "termination_date": "20220715",
      "report_date": "20200610",
      "code_info": "UDI: (01)00887868324840; Lot Numbers: C19H0013  C19I0009  C19J0009  C19K0010  C20A0003  SBM108408  SBM118990"
    }
  ]
}