{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Plainsboro",
      "address_1": "311 Enterprise Dr",
      "reason_for_recall": "The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term \"bone marrow aspirate\". The term is incorrectly translated in Spanish and French,",
      "address_2": "",
      "product_quantity": "42 units",
      "code_info": "Putty Part Number 7700713001  510 K- K062353  Device Listing Number - E604163    Integra MOZAIKTM Putty 2.5cc  Reference No. - PTY10125ITL  Batch number - 105BR02l5949    Integra MOZAIKTM Putty 5cc  Refernce No. - PTY10155ITL  Batch No. - 105BR0216024    Integra MOZAIKTM Putty lOcc  Reference No.- PTY10210ITL  Batch No. - 105BR0215956",
      "center_classification_date": "20120612",
      "distribution_pattern": "Worldwide Distribution",
      "state": "NJ",
      "product_description": "Integra Mozaik Putty  2.5cc, 5 cc, 10 cc       Product Usage:  The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.",
      "report_date": "20120620",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Integra LifeSciences Corp.",
      "recall_number": "Z-1796-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "61717",
      "termination_date": "20130214",
      "more_code_info": "",
      "recall_initiation_date": "20111011",
      "postal_code": "08536-3344",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}