{
  "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": "Arlington",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78150",
      "recalling_firm": "MicroPort Orthopedics Inc.",
      "address_1": "5677 Airline Rd",
      "address_2": "N/A",
      "postal_code": "38002-9501",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of  TX, AL, AZ CO, KS ,ME MO, WB, LA, CA, MD, including PR  and the country  of  CANADA",
      "recall_number": "Z-0043-2018",
      "product_description": "MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R    Product Usage:  MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed",
      "product_quantity": "48 units",
      "reason_for_recall": "The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the product\u0019s sterility assurance and may lead to serious adverse events such as infections, both localized and systemic.",
      "recall_initiation_date": "20170918",
      "center_classification_date": "20171020",
      "termination_date": "20210408",
      "report_date": "20171101",
      "code_info": "lot 1723305"
    }
  ]
}