FDA recall Z-0665-2018

Ivoclar Vivadent, Inc. · Class III · device

Product

Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

Reason for recall

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

Distribution

US and Canada

Key facts

Status: Terminated
Initiation date: 2017-08-03
Report date: 2018-02-28
Termination date: 2018-08-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Amherst, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0665-2018