{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217914",
      "product_res_number": "Z-1133-2026",
      "event_date_initiated": "2025-12-19",
      "event_date_posted": "2026-01-20",
      "recall_status": "Open, Classified",
      "res_event_number": "98220",
      "product_code": "N/A",
      "product_description": "Brand Name: MicroPort\nProduct Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE\nModel/Catalog Number: HTHT0036\nSoftware Version: N/A\nProduct Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE",
      "code_info": "Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary\nDevice ID M684HTHT00361",
      "firm_fei_number": "3010536692",
      "recalling_firm": "MicroPort Orthopedics Inc.",
      "address_1": "5677 Airline Rd",
      "city": "Arlington",
      "state": "TN",
      "postal_code": "38002-9501",
      "additional_info_contact": "Trey Haire\n+1-901-8674314",
      "reason_for_recall": "Due to products not having FDA Premarket authorization to be distributed within the United States.",
      "root_cause_description": "No Marketing Application",
      "action": "On 12/19/2025, the firm email an \"MicroPort Voluntary Recall - R25120001 HIPTURN Femoral Trial Head\" communication to customers informing them that MicroPort was\nnotified by the FDA that this device was not properly classified as a CLASS I device. MicroPort has decided not to pursue clearance of the device with a new FDA 510(k) submission and therefore has initiated field action to remove the device from the market.\n\nCustomer are instructed to return the complete kits to MicroPort Orthopedics.\n\nFor Questions - contact Bryan Callahan at 901-867-4594 or email address bryan.callahan@ortho.microport.com",
      "product_quantity": "91",
      "distribution_pattern": "The product was sent to distributors in multiple US states, including Texas, California, Wisconsin, Kansas,\nIllinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and Florida.\n\nThe product was also sent to the following countries: Belgium, Germany, France, Italy, United Kingdom, Japan, and China.",
      "openfda": {}
    }
  ]
}