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.
Recall
- Recall Number
- Z-0746-2022
- Event Number
- 89534
- Firm
- Envisiontec US Llc
- FEI Number
- 3009261582
- Product Code
- EBZ
- Status
- Open, Classified
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- January 20, 2022
- Address
- 15162 S Commerce Dr, Dearborn, MI, 48120-1237
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.
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
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: [email protected] 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.
US Nationwide
172 units