FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Recall
- Recall Number
- Z-0643-2022
- Event Number
- 89449
- Firm
- Envisiontec US Llc
- FEI Number
- 3009261582
- Product Code
- EBI
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- January 6, 2022
- Address
- 15162 S Commerce Dr, Dearborn, MI, 48120-1237
Description
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
ENVISIONTEC 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 [email protected]. For other inquiries regarding these products, please contact EnvisionTec customer service at nvisiontec.com/support.
US Nationwide distribution.
795 units