PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this reca
Summary
The FDA issued a Class II for PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing by Envisiontec US Llc. Reason: The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications..
Details
Source
Device Recall
External ID
Z-0746-2022
Action Date
2022-03-16
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: All units SKU number ACC-06-1000
Quantity Affected: 172 units
Reason for Recall
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-20
Company
Dearborn, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Envisiontec US Llc has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Envisiontec US Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Envisiontec US Llc have FDA actions?
Envisiontec US Llc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0746-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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