{
  "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": "141991",
      "product_res_number": "Z-0475-2016",
      "event_date_initiated": "2014-06-09",
      "event_date_posted": "2015-12-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-02-05",
      "res_event_number": "72695",
      "product_code": "LZJ",
      "k_numbers": [
        "K132496"
      ],
      "product_description": "Total Toe Instrument Kit, Labeled in part: \"Instrument Set, 15mm Toe, Dorsal Flange Combi\" Part Number: 9000-3002 \n\nThe component in question is the hex driver (part number 2009-4001).",
      "code_info": "SN 000242 SN 000244 SN 000246 SN 000247",
      "firm_fei_number": "3004154314",
      "recalling_firm": "Arthrosurface, Inc.",
      "address_1": "28 Forge Pkwy",
      "city": "Franklin",
      "state": "MA",
      "postal_code": "02038",
      "additional_info_contact": "Dawn Wilson\n508-520-3003",
      "reason_for_recall": "An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.",
      "root_cause_description": "Process change control",
      "action": "The distributors were verbally notified, and replacement Rev F Hex Drivers sent to the locations of the kits. The kits had been moved in preparation for upcoming surgeries, but the Drivers were replaced prior to any additional surgery taking place. No affected product remains in the field. For further questions, please call  (508) 520-3003.",
      "product_quantity": "3 units",
      "distribution_pattern": "US Distribution to the states of : PA, WV and CA.",
      "openfda": {
        "k_number": [
          "K884561",
          "K922211",
          "K072251",
          "K920667",
          "K102549",
          "K950864",
          "K924724",
          "K132496",
          "K941650",
          "K920446",
          "K911552"
        ],
        "registration_number": [
          "1020279",
          "3003477135",
          "3004154314",
          "3011277306",
          "3006017180",
          "2028632",
          "1649518",
          "2027754",
          "2029275"
        ],
        "fei_number": [
          "1020279",
          "3003477135",
          "3004154314",
          "1000306431",
          "3011277306",
          "3006017180",
          "3001236277",
          "2027754",
          "1000125025"
        ],
        "device_name": "Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      }
    }
  ]
}