Z-0376-2019 Class II Terminated
FDA device recall Z-0376-2019 was initiated by Coltene Whaledent Inc on August 21, 2018 and is designated Class II. Reason for recall: ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 The recall status is terminated (terminated April 10, 2020). Affected quantity: 30 packets.
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2018
- Initiation Date
- August 21, 2018
- Termination Date
- April 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 packets
Product 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.
Reason for Recall
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
Distribution Pattern
US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.
Code Information
Batch I33012