{
  "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": "2026-08-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99332",
      "recalling_firm": "IsoTis OrthoBiologics, Inc.",
      "address_1": "2 Goodyear Ste A",
      "address_2": "N/A",
      "postal_code": "92618-2052",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.",
      "recall_number": "Z-2820-2026",
      "product_description": "OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095.  Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095",
      "product_quantity": "98",
      "reason_for_recall": "Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 ¿ 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.",
      "recall_initiation_date": "20260702",
      "center_classification_date": "20260728",
      "report_date": "20260805",
      "code_info": "REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550"
    }
  ]
}