{
  "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,
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    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Miami",
      "address_1": "6303 Blue Lagoon Dr Ste 100",
      "reason_for_recall": "Device and tray that houses the device did not pass steam sterilization process validation testing",
      "address_2": "",
      "product_quantity": "136 units",
      "code_info": "All lots",
      "center_classification_date": "20200612",
      "distribution_pattern": "Nationwide  Foreign: CHINA, AUSTRALIA,  CHILE,  COSTA RICA , NETHERLANDS,  SWITZERLAND",
      "state": "FL",
      "product_description": "Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument  Product Code: 14235",
      "report_date": "20200624",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Biomet",
      "recall_number": "Z-2362-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "85641",
      "termination_date": "20210728",
      "more_code_info": "",
      "recall_initiation_date": "20200501",
      "postal_code": "33126-6023",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}