Recall Z-0376-2019 ยท ELR Post, Root Canal
Coltene Whaledent Inc
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.
| Date | Aug 21, 2018 |
| Status | Terminated |
| Reason | ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 |
| Root cause | 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. If you should have additional questions, please contact Regulatory Affairs Manager, at 330-9 |
| Quantity | 30 packets |
| Distribution | US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.