{
  "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": "Hillsboro",
      "address_1": "5885 NW Cornelius Pass Rd",
      "reason_for_recall": "Manufacturing of these devices with a grade of stainless steel that is not within specifications.",
      "address_2": "",
      "product_quantity": "141 units in the US; 294 units outside the US.",
      "code_info": "2.0mm x 80mm SS cable/sleeve: Lot # 222078, 232175, 245032, 254368, 261903, 270659, 284155, 297281.    2.0mm SS sleeve only: Lot # 247553, 267469, 280871, 313261.    8, 7 hole SS compression plate: Lot # 300381.    10, 9 hole SS compression plate: Lot # 299641.",
      "center_classification_date": "20140425",
      "distribution_pattern": "US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY.    Product was distributed outside the US to: Australia, China,  Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.",
      "state": "OR",
      "product_description": "The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. .     2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S  2.0 mm SS Sleeve Only; Part Number 01-0022-S  8, 7 hole, SS compression plate; Part Number 02-2007-S  10, 9 hole, SS compression plate; Part Number 02-2009-S    Product Usage:  The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate.  It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures.  The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures",
      "report_date": "20140507",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Acumed LLC",
      "recall_number": "Z-1515-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67885",
      "termination_date": "20150204",
      "more_code_info": "",
      "recall_initiation_date": "20140326",
      "postal_code": "97124-9432",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}