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Terminated

Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.

FDA Recall Z-1676-2021 · Posted None

Recalling FirmDentech Corp.
Recall StatusTerminated
Product CodeEEF
Date Initiated2021-04-21
Date Terminated2023-01-12
Product Quantity87,842 UNITS

Reason for Recall

Removing parts for safety reasons due to possible breakage.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

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, Sweden, Netherland, France, Poland, Slovenia, Bulgaria, Norway and Romania.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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