{
  "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": {
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  "results": [
    {
      "cfres_id": "186441",
      "product_res_number": "Z-1494-2021",
      "event_date_initiated": "2021-03-18",
      "event_date_created": "2021-04-26",
      "recall_status": "Open, Classified",
      "res_event_number": "87645",
      "product_code": "EBL",
      "product_description": "Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741",
      "code_info": "Lot/Batch number:    K39841",
      "firm_fei_number": "2416455",
      "recalling_firm": "Coltene Whaledent Inc",
      "address_1": "235 Ascot Pkwy",
      "city": "Cuyahoga Falls",
      "state": "OH",
      "postal_code": "44223-3701",
      "additional_info_contact": "Nancy Spencer\n330-916-8995",
      "reason_for_recall": "The incorrect dental pins were packaged and subsequently distributed.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 3/18/2021, Coltene issued an Urgent Medical Device Recall notice via letter to customers notifying them the incorrect dental pins were packaged and subsequently distributed. The TMS LINK PLUS Self-Threading L741 Pins should be stainless steel, single sheer link pins that are gold-plated. The pins that were packed and distributed are titanium, double sheer, and not gold plated. The incorrectly packaged pin is too small for the drill, resulting in a hole that may be drilled too large for the pins. The pins may not engage the hole to effectively sheer.",
      "product_quantity": "65 packs of 20 pins",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela.",
      "openfda": {
        "device_name": "Pin, Retentive And Splinting, And Accessory Instruments",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.3740",
        "device_class": "1",
        "k_number": [
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