Recall Z-1676-2021 ยท EEF Clamp, Rubber Dam
Dentech Corp.
Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
| Date | Apr 21, 2021 |
| Status | Terminated |
| Reason | Removing parts for safety reasons due to possible breakage. |
| Root cause | Component design/selection |
| Action | On 04/21/21 the firm sent an email to its distributors with the following instructions: 1. Please identify the products first by "Lot No", "Product Code", Shipment date" and stop using and selling those items. 2.Inform DENTECH of total quantity of defective products. We will replace all of them free of charge once available. 3. Please return affected product to Dentech. |
| Quantity | 87,842 UNITS |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, MN, KY, WA and the countries of Russia, Libya, Moldova, China, Egypt, India, Canada, Guatemala, Iraq, Saudi Araba, Australia, Ukraine, Israel, Indonesia, Malaysia, UK, Singapore, South Korea, Georgia, Taiwan Lithuania, Greece, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.