{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Sydney",
      "state": "N/A",
      "country": "Australia",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79219",
      "recalling_firm": "Signature Orthopedics Pty Limited",
      "address_1": "7 Sirius Road",
      "address_2": "Lane Cove West",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - U.S. Nationwide and the country of Australia.",
      "recall_number": "Z-0920-2018",
      "product_description": "Signature Ceramic Femoral Head. Model Number: 111-152-621.  The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta).  The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within  the Logical Acetabular Cups.    Product Usage:  Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: ¿ Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ¿ Inflammatory joint disease including rheumatoid arthritis ¿ Correction of functional deformity including congenital hip dysplasia ¿ Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ¿ Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement",
      "product_quantity": "10",
      "reason_for_recall": "This recall has been identified due to the batch being mislabeled, with the packaged  component's size not corresponding to the label. Therefore, the product intended to be used  for the procedure may not be included in the packaging resulting in surgical delay as  replacement product is retrieved.",
      "recall_initiation_date": "20180202",
      "center_classification_date": "20180306",
      "termination_date": "20180808",
      "report_date": "20180314",
      "code_info": "UDI: 09348215001926. Lot:78560."
    }
  ]
}