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.
- Company
- Envisiontec Us Llc
- Recall Initiated
- January 20, 2022
- Recall Number
- Z-0746-2022
- Quantity
- 172 units
- Firm Location
- Dearborn, MI
Reason for Recall
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
Distribution
US Nationwide
Lot / Code Info
All units SKU number ACC-06-1000
Root Cause
Unknown/Undetermined by firm
Action Taken
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 product. This recall is being carried out only for the specific products identified above; no other products are involved in this recall. Notifications of this recall are being sent to all accounts to whom EnvisionToc shipped a recalled product. For customers that redistribute this product to other accounts, please notify your accounts. For questions about the recall process please contact Sedgwick at 1-866-512-4073. For other inquiries regarding these products and to initiate your return, please contact Envision Tac customer service at envisiontec.com/support (if you do not have access to the Internet, contact Sedgwick at the toll-free number above with your contact information and EnvisionTec customer service will promptly contact you to arrange your return). A replacement curing unit of equal or greater value will be provided to customers; if replacement is not available, a credit will be issued to customers at the price in effect at the time of purchase.