{
  "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",
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      "cfres_id": "167379",
      "product_res_number": "Z-0376-2019",
      "event_date_initiated": "2018-08-21",
      "event_date_created": "2018-11-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-04-10",
      "res_event_number": "81065",
      "product_code": "ELR",
      "product_description": "ParaPost Plus 25  Titanium Alloy  Spiral Vented and \nSerrated  Posts \nCatalog Number: P2845B\n\nDental Posts are implanted into teeth 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.",
      "code_info": "Batch I33012",
      "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": "330-916-8858",
      "reason_for_recall": "ParaPost Plus Titanium Posts contain stainless steel post that are a size 4",
      "root_cause_description": "Process control",
      "action": "The firm, Coltene, issued an \"Urgent Medical Device Recall\" Letter dated August 20, 2018 to the customers on August 21st via email with a delivery and read receipt requested.  The letter described the product, problem and actions to be taken. The customers were instructed to return the product to Coltene/Whaledent Inc.; return any unused product and we will replace your product at no cost, and complete and return the Return Response Form via email:  tricia.cregger@coltene.com or Phone: 330-916-8817.\n\nIf you should  have additional questions, please contact  Regulatory Affairs Manager, at 330-916-8904 and  Tricia.Cregger@coltene.com.",
      "product_quantity": "30 packets",
      "distribution_pattern": "US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.",
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