Dearborn, MI, United States
Envisiontec US Llc recalls
2 recalls recorded since 2018, most recently on 20 January 2022. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 January 2022
- Reason
- The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0746-2022
- 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.
Ongoing Class II Medical devices
- Recall started
- 6 January 2022
- Reason
- Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0643-2022, Z-0642-2022
- FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
- FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.