{
  "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": "Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.",
      "address_2": "",
      "product_quantity": "2544 unit in the US and 3584 units outside the US",
      "code_info": "50.0 mm Tension Band Pin:  Lot 243639  70.0 mm Tension Band Pin:  Lots 241127, 242707, 243325, 243948.  90.0 mm Tension Band Pin:  Lots 241128. 242708, 243327, 243949.    50.0 mm Tension Band Kit: Lots 216769, 217002, 217941, 219145, 219402, 222732, 223007, 224312, 229889, 232575, 235490, 237772, 244800, 246204, 247056.    70.0 mm Tension Band Kit:  Lots 210290, 211349, 214574, 215405, 217004, 218273, 219230, 220978, 221503, 223008, 223477, 224066, 225554, 227193, 229394, 230287, 230952, 231971, 233742, 235502, 237773, 240512, 241185, 243617, 243945, 244801, 246777, 246779, 246938, 247108, 247109, 247493.    90.0 mm Tension Band Kit: Lots 215053, 217005, 218600, 218700, 221465, 222731, 223009, 223756, 225555, 228951, 231573, 236969, 237774, 243620, 244802, 246939, 246990, 247381.",
      "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 Acumed Tension Band Pin is a fixation pin which is .0625\" in diameter and is available in lengths between 35mm and 90mm.  It is to be used in conjunction with commonly used orthopedic wire.    50.0 mm Tension Band Pin;  Part Number 30-0097  70.0 mm Tension Band Pin;  Part Number 30-0098  90.0 mm Tension Band Pin;  Part Number 30-0099  50.0 mm Tension Band Kit;  Part Number TB-1550K-S  70.0 mm Tension Band Kit;  Part Number TB-1570K-S  90.0 mm Tension Band Kit;  Part Number TB-1590K-S    Product Usage:  Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.",
      "report_date": "20140507",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Acumed LLC",
      "recall_number": "Z-1516-2014",
      "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"
    }
  ]
}