{
  "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": [
    {
      "status": "Terminated",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71899",
      "recalling_firm": "Ortho Solutions Inc",
      "address_1": "330 Franklin Tnpk",
      "address_2": "N/A",
      "postal_code": "07430",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.",
      "recall_number": "Z-0026-2016",
      "product_description": "Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile    Orthopaedic Bone Screw",
      "product_quantity": "875 units",
      "reason_for_recall": "Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification.  As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternativ",
      "recall_initiation_date": "20150714",
      "center_classification_date": "20151006",
      "termination_date": "20170426",
      "report_date": "20151014",
      "code_info": "Part Number (Lot Number) infomration is as follows:  OS421712-NS (lot 7891), OS421714-NS (lot 7891)  OS421716-NS (lot 7891, 7520), OS421718-NS (lot 7891, 7520)  OS421720-NS (lot 7891), OS421722-NS (lot 7891, 7520)  OS421724-NS (lot 7891, 7520), OS421726-NS (lot 7891)  OS421728-NS (lot 7891), OS421730-NS (lot 7891)  OS421735-NS (lot 7520, 7891) ,OS421740-NS (lot 7520, 7891)  OS421745-NS (lot 7520, 7891) ,OS421750-NS (lot 7520, 7891)  OS421716 (lot 7519) ,OS421718 (lot 7519)"
    }
  ]
}