FDA recall Z-1100-2022

Product

Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912

Reason for recall

Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK

Distribution

Distributed in SC.

Key facts

Status

Terminated

Initiation date

2022-03-18

Report date

2022-05-25

Termination date

2024-03-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brookfield, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1100-2022