{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "214683",
      "product_res_number": "Z-2222-2025",
      "event_date_initiated": "2025-06-18",
      "event_date_posted": "2025-07-31",
      "recall_status": "Open, Classified",
      "res_event_number": "97126",
      "product_code": "KYJ",
      "k_numbers": [
        "K140453"
      ],
      "product_description": "Brand Name: Osteotec\r\nProduct Name: Osteotec Silicone Finger Implant\r\nModel/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5)\r\nSoftware Version: N/A\r\nProduct Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which\r\nis placed, during arthroplasty, in the proximal and distal intramedullary canals of either\r\nmetacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the\r\nbones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes\r\nto meet various anatomical variations and is supplied sterile.\r\nComponent: N/A",
      "code_info": "Lot Code: OSTF-3 LOT 127707 Exp 07/17/2028, UDI-DI:5060183090040\nOSTF-4 LOT 127708 Exp 07/17/2028, UDI-DI:5060183090057\nOSTF-5 LOT 127709 Exp 07/17/2028, UDI-DI:5060183090064",
      "firm_fei_number": "3008395366",
      "recalling_firm": "Osteotec Limited",
      "address_1": "Unit 9 Silver Business Park Airfield Way",
      "address_2": "Unit 9",
      "city": "Christchurch",
      "country": "United Kingdom",
      "additional_info_contact": "Timothy Allard\n0-1202 487885",
      "reason_for_recall": "There is the potential that the silicone implant may contain foreign material",
      "root_cause_description": "Process change control",
      "action": "On June 18, 2025, Osteotec issued an Urgent Medical Device Recall Notification via E-Mail. Osteotec asked consignees to take the following actions:\n\n1.\tImmediately review your inventory and quarantine any of the affected LOTs. \n2.\tIf a physician has successfully implanted the device, they physician should continue to monitor the implant for any infections or issues. If a physician has successfully implanted a device that potentially could contain foreign material, it is recommended that they continue to monitor the patient for any infections or issues associated with the recalled device.\n3.\tShare this Product Recall letter within your facility network and forward to any customers to whom you have distributed products from the affected LOTs to ensure awareness.\n4.\tComplete and return the attached response and acknowledgement form to Osteotec.\n5.\tReturn affected products to your Agent/Distributor/Osteotec",
      "product_quantity": "15573 units",
      "distribution_pattern": "US Nationwide distribution in the state of CA.",
      "openfda": {
        "k_number": [
          "K781668",
          "K970544",
          "K211385",
          "K022892",
          "K083107",
          "K233670",
          "K931588",
          "K140453",
          "K001922",
          "K220142",
          "K013629",
          "K781380",
          "K870200",
          "K082231"
        ],
        "registration_number": [
          "3014596751",
          "1020279",
          "2031009",
          "1834331",
          "1000286794",
          "3010372554",
          "3002894438",
          "3003477135",
          "1818910",
          "1649379",
          "3016669046",
          "3002807310",
          "3007366790",
          "1226544",
          "3024706750",
          "3008395366",
          "2183946",
          "1221934",
          "3015239144",
          "3008868758"
        ],
        "fei_number": [
          "3014596751",
          "1000116116",
          "1020279",
          "3007282753",
          "1000286794",
          "3010372554",
          "3001236812",
          "3002894438",
          "3003477135",
          "1818910",
          "3016669046",
          "3002807310",
          "3024706750",
          "3000718490",
          "1000306340",
          "3003128516",
          "3008395366",
          "1221934",
          "3015239144",
          "3008868758"
        ],
        "device_name": "Prosthesis, Finger, Constrained, Polymer",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3230",
        "device_class": "2"
      }
    }
  ]
}