Recall Z-0376-2019
Coltene Whaledent Inc · initiated August 21, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Batch I33012
Reason for recall
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
FDA-determined 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.
Details
- Recall number
- Z-0376-2019
- Initiated
- August 21, 2018
- Terminated
- April 10, 2020
- Product code
- ELR – Post, Root Canal
- Quantity
- 30 packets
- Distribution
- US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.
- Recalling firm
- Coltene Whaledent Inc, Cuyahoga Falls, OH