FDA recall Z-0746-2022

Product

PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.

Reason for recall

The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.

Distribution

US Nationwide

Key facts

Status

Ongoing

Initiation date

2022-01-20

Report date

2022-03-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dearborn, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0746-2022