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.
FDA Recall Z-0746-2022 · Posted None
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Recalling FirmEnvisiontec US Llc
Recall StatusOpen, Classified
Product CodeEBZ
Date Initiated2022-01-20
Product Quantity172 units
Reason for Recall
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
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: [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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
US Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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