Coltene Whaledent Inc: Medical Device Recall in 2018 - (Recall #: Z-0376-2019)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2018.
Data Source: FDA.
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.
Product Classification:
Class II
Date Initiated: August 21, 2018
Date Posted: November 14, 2018
Recall Number: Z-0376-2019
Event ID: 81065
Reason for Recall:
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
Status: Terminated
Product Quantity: 30 packets
Code Information:
Batch I33012
Distribution Pattern:
US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.
Voluntary or Mandated:
Voluntary: Firm initiated