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.
Recall
- Recall Number
- Z-0376-2019
- Event Number
- 81065
- Firm
- Coltene Whaledent Inc
- FEI Number
- 2416455
- Product Code
- ELR
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- August 21, 2018
- Terminated
- April 10, 2020
- Address
- 235 Ascot Pkwy, Cuyahoga Falls, OH, 44223-3701
Description
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.
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
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: [email protected] or Phone: 330-916-8817. If you should have additional questions, please contact Regulatory Affairs Manager, at 330-916-8904 and [email protected].
US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.
30 packets