Recall Z-0643-2022 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
Envisiontec US Llc
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
| Date | Jan 6, 2022 |
| Status | Open, Classified |
| Reason | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin |
| Root cause | Nonconforming Material/Component |
| Action | 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 Indi |
| Quantity | 795 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.