{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Franklin Lakes",
      "address_1": "509 Commerce St",
      "reason_for_recall": "During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.",
      "address_2": "",
      "product_quantity": "347 units",
      "code_info": "Lot BMCXU11P1. BMCXU11H3    Lot BMCXU11P1, BMCXU12P1",
      "center_classification_date": "20160311",
      "distribution_pattern": "US Distribution to state of: MA.",
      "state": "NJ",
      "product_description": "NuOss XC Sinus  Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height)  Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height)    Manufacturer:- Collagen Matrix,   Distributor:- ACE Surgical Supply Co, Inc,     Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration",
      "report_date": "20160323",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Collagen Matrix Inc",
      "recall_number": "Z-1097-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "73206",
      "termination_date": "20170621",
      "more_code_info": "",
      "recall_initiation_date": "20130513",
      "postal_code": "07417-1374",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}