{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "92968",
      "product_res_number": "Z-0438-2011",
      "event_date_initiated": "2010-07-12",
      "event_date_posted": "2010-11-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-06-30",
      "res_event_number": "56215",
      "product_code": "KYI",
      "k_numbers": [
        "K041451"
      ],
      "product_description": "The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469,  is a single-use uncemented, one-component prosthesis for the basal thumb joint.\n\nThe NuGrip is intended to replace the proximal end of the first metacarpal.",
      "code_info": "Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469",
      "firm_fei_number": "3002788818",
      "recalling_firm": "Ascension Orthopedics, Inc",
      "address_1": "8700 Cameron Rd Ste 100 8700 Cameron Rd",
      "address_2": "Ste 100",
      "city": "Austin",
      "state": "TX",
      "postal_code": "78754",
      "additional_info_contact": "Ken Thoma\n512-836-5001 Ext. 1513",
      "reason_for_recall": "Two different product lots were found to be incorrectly labeled and placed into the incorrect box.",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "Ascension Orthopedics notified by phone on June 25, 2010 and sent  a letter dated July 22, 2010, to all customers. The customers were instructed to return the devices to the firm.\n\nShould you have any questions or concerns please feel free to contact (512) 836-5001 ext 1585.",
      "product_quantity": "10",
      "distribution_pattern": "Worldwide distribution: USA including states of: IL, IN, MD, OH,  and TN; and countries of : Puerto Rico and Netherlands.",
      "openfda": {
        "k_number": [
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          "K111068",
          "K964381",
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          "K790508",
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          "K042690",
          "K964472",
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        ],
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        "fei_number": [
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          "3009826895",
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          "3006742481",
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          "3009322142",
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          "3009513193",
          "3007993775"
        ],
        "device_name": "Prosthesis, Wrist, Carpal Trapezium",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3770",
        "device_class": "2"
      }
    }
  ]
}