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U.S. Department of Health and Human Services

Class 2 Device Recall EGuard PCA 4000 Curing Units

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 Class 2 Device Recall EGuard PCA 4000 Curing Unitssee related information
Date Initiated by FirmJanuary 20, 2022
Create DateMarch 10, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0746-2022
Recall Event ID 89534
510(K)NumberK201173 
Product Classification Activator, ultraviolet, for polymerization - Product Code EBZ
ProductPCA 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.
Code Information All units SKU number ACC-06-1000
FEI Number 3009261582
Recalling Firm/
Manufacturer		 Envisiontec US Llc
15162 S Commerce Dr
Dearborn MI 48120-1237
For Additional Information ContactMiguel Gomez
313-436-4300
Manufacturer Reason
for Recall		The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionThe 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.
Quantity in Commerce172 units
DistributionUS Nationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EBZ
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