ParaPost 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.
- Company
- Coltene Whaledent Inc
- Recall Initiated
- August 21, 2018
- Terminated
- April 10, 2020
- Recall Number
- Z-0376-2019
- Quantity
- 30 packets
- Firm Location
- Cuyahoga Falls, OH
Reason for Recall
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
Distribution
US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.
Lot / Code Info
Batch I33012
Root Cause
Process control
Action Taken
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. If you should have additional questions, please contact Regulatory Affairs Manager, at 330-916-8904 and Tricia.Cregger@coltene.com.