Recall Z-0746-2022 ยท EBZ Activator, Ultraviolet, For Polymerization
Envisiontec US Llc
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.
| Date | Jan 20, 2022 |
| Status | Open, Classified |
| Reason | The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm, Evisiontec US LLC., sent "URGENT: PRODUCT RECALL" notification letters dated 1/20/22 to customers. ACTION: 1. Stop utilizing the PCA 4000 to print medical devices made from EnvisionTec dental resins. 2. Please carry out a physical count and record this data on the Recall Response Form included with this letter. 3. Submit the Recall Response Form by e-mail: envisiontec4279@sedgwick.com or fax to: 866-875-0545 even if you do not have the recalled product. 4. Contact EnvisionTec customer service at envisiontec.com/support to arrange for the return and replacement of the recalled produc |
| Quantity | 172 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201173 | E-Guard Envisiontec GmbH, Nov 27, 2020 |