Z-0376-2019 Class II Terminated
FDA device recall Z-0376-2019 was initiated by Coltene Whaledent Inc on Aug 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 Apr 10, 2020). Affected quantity: 30 packets.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 14, 2018
- Initiation Date
- Aug 21, 2018
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0376-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026