{
  "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 {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l 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": "22 units",
      "code_info": "Strip Part Number 7701513001    510 K- K063124  Device Listing Number - D001098    Integra MOZAIKTM Strip IOcc  Reference number - CCM I021OITL  Batch Number - 105BR0215955    Integra MOZAIKTM Strip 10cc  Reference Number - CCM I021OITL  Batch Number - 105BR0216149",
      "center_classification_date": "20120612",
      "distribution_pattern": "Worldwide Distribution",
      "state": "NJ",
      "product_description": "Integra Mozaik Strip   10 cc     Product Usage:  The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-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-1795-2012",
      "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"
    }
  ]
}