{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Westlake Village",
      "address_1": "3050 E Hillcrest Dr",
      "reason_for_recall": "Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect  color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.",
      "address_2": "",
      "product_quantity": "11 units",
      "code_info": "Lot # 109038  No affected devices distributed within the US.",
      "center_classification_date": "20200210",
      "distribution_pattern": "US: None  OUS: Iceland, Sweden, Spain,",
      "state": "CA",
      "product_description": "SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708",
      "report_date": "20200219",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Implant Direct Sybron Manufacturing LLC",
      "recall_number": "Z-1126-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "84706",
      "termination_date": "20210427",
      "more_code_info": "",
      "recall_initiation_date": "20190109",
      "postal_code": "91362-3171",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}