Z-0746-2022 Class II Ongoing
FDA device recall Z-0746-2022 was initiated by Envisiontec US Llc on January 20, 2022 and is designated Class II. Reason for recall: The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications. The recall status is ongoing. Affected quantity: 172 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2022
- Initiation Date
- January 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 172 units
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.
Reason for Recall
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
Distribution Pattern
US Nationwide
Code Information
All units SKU number ACC-06-1000