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U.S. Department of Health and Human Services

Class 2 Device Recall FLEXCERA BASE

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 Class 2 Device Recall FLEXCERA BASEsee related information
Date Initiated by FirmJanuary 06, 2022
Create DateFebruary 15, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0642-2022
Recall Event ID 89449
Product Classification Resin, denture, relining, repairing, rebasing - Product Code EBI
ProductFLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
Code Information Manufactured from April 1, 2021 to September 15, 2021. 120421-a 70921 30521 180621d 010421 140621a 060721a 120421-b 270521 130521a 090721a 060421-a 140621b 060721b 120421-c 030621 130521b 090721b 060421-b 140621c 060721c 220421-a 160721a 130521c 130721a 060421-c 150621a 060721d 220421-b 160721b 200521a 130721b 080421-a 150621b 070721a 220421-c 180721 200521b 130721c 080421-b 150621c 070721b 230621a 280721 200521c 130721d 080421-c 210621a 070721c 230621b 290721 250521a 300821a 130421-a 210621b 070721d 230621c 100821 250521b 300821b 130421-b 210621c 080721a 230621d 100821 250521c 310821a 130421-c 210621d 080721b 170721a 090621c 310521a 210721a 200421-a 220621a 080721c 170721b 180721a 310521b 210721b 200421-b 220621b 080721d 190721 180721b 310521c 210721c 200421-c 220621c 120721a 290721a 180721c 070621a 40821 260421-a 220621d 120721b 290721b 180721d 070621b 60821 260421-b 300621a 120721c 290721c 190721a 070621c 130821 260421-c 300621b 120721d 90821 190721b 110621a 090921-2 270421-a 300621c 140721a 110821 160821 110621b 100921 270421-b 300621d 140721b 120821 270821 110621c 140921-1 270421-c 050721a 140721c 190821 190421a 180621a 140921-2 030521 050721b 140721d 230821 190421b 190621b 140921-3 040521a 050721c 150721a 240821 190421c 180621c 140921-4 040521b 050721d 200721a 070421-a 210421-a 260521a 290621a 040521c 310821b 200721b 070421-b 210421-b 260521b 290621b 170521a 010921a 200721c 070421-c 210421-c 160621a 290621c 170521b 010921b 200721d 170821 280721a 160621b 290621d 170521c 020921a 300721a 180821 280721b 160621c 280621a 180521a 020921b 300721b 110521 280721c 160621d 280621b 180521b 030921a 300721c 200821 030821a 170721 280621c 180521c 030921b 50821 020621 030821b 140421-b 280621d 190521a 070921 200421 030821c 140421-a 020821a 090621a 080921 250821 130921-1 180821b 020821b 090621b 080921-2 260821 130921-2 100921-2 020821c 090921 140421-c
FEI Number 3009261582
Recalling Firm/
Manufacturer		 Envisiontec US Llc
15162 S Commerce Dr
Dearborn MI 48120-1237
For Additional Information Contact Miguel Gomez
313-436-4300
Manufacturer Reason
for Recall		Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
FDA Determined
Cause 2		Nonconforming Material/Component
ActionENVISIONTEC US LLC issued Urgent Medical Device Recall letter on Jan 6, 2022. Letter states reason for recall, health risk and action to take: 1. Stop dispensing and distributing and quarantine these lots. 2. Please carry out a physical count and record this data on the Products Recall Response Form included with this letter. 3. Submit the Products Recall Response Form via email or fax even if you do not have the recalled product. 4. Contact Sedgwick as instructed in the Products Recall Response Form and return the recalled product to: Sedgwick Attn: Event 7788 2670 Executive Dr., Suite A Indianapolis, IN 46241 Notifications of this recall are being sent to all direct accounts of EnvisionTec US LLC For customers that redistribute this product to other accounts, please notify your accounts. No other lots, packages, or formulations are being recalled. For shipping assistance or questions about the recall process please contact Sedgwick at 1-888-759-6907 (phone), 1-866-462-9941 (fax) and envisiontec7788@sedgwick.com. For other inquiries regarding these products, please contact EnvisionTec customer service at nvisiontec.com/support.
Quantity in Commerce574 units
DistributionUS Nationwide distribution.
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.
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