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U.S. Department of Health and Human Services

Class 2 Device Recall ParaPost Plus Posts

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 Class 2 Device Recall ParaPost Plus Postssee related information
Date Initiated by FirmAugust 21, 2018
Create DateNovember 02, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall NumberZ-0376-2019
Recall Event ID 81065
Product Classification Post, root canal - Product Code ELR
ProductParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental 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 Information Batch I33012
FEI Number 2416455
Recalling Firm/
Manufacturer		 Coltene Whaledent Inc
235 Ascot Pkwy
Cuyahoga Falls OH 44223-3701
For Additional Information Contact
330-916-8858
Manufacturer Reason
for Recall		ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
FDA Determined
Cause 2		Process control
ActionThe 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. If you should have additional questions, please contact Regulatory Affairs Manager, at 330-916-8904 and Tricia.Cregger@coltene.com.
Quantity in Commerce30 packets
DistributionUS Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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