{
  "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": "Plainsboro",
      "address_1": "311 Enterprise Dr",
      "reason_for_recall": "As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA.",
      "address_2": "",
      "product_quantity": "467 devices",
      "code_info": "Lot/Serial Number: 111602, 110864, 102815, 091515, 092563, 110863.  Product/Catalogue No: CMC-410-10, CMC-410-20, CMC-410-30, CMC-410-40.",
      "center_classification_date": "20130621",
      "distribution_pattern": "USA Nationwide Distribution",
      "state": "NJ",
      "product_description": "CMC Saddle    Product Usage:  The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.",
      "report_date": "20130703",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Integra LifeSciences Corp.",
      "recall_number": "Z-1568-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "65362",
      "termination_date": "20141008",
      "more_code_info": "",
      "recall_initiation_date": "20130603",
      "postal_code": "08536-3344",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}