FDA Recall Terminated

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

Recall: Z-1676-2021 · Initiated April 21, 2021

Recall

Recall Number
Z-1676-2021
Event Number
87847
Firm
Dentech Corp. 53 Shimizu-Cho, Itabashi-Ku Tokyo Japan
FEI Number
3002809535
Product Code
EEF
Status
Terminated
Root Cause
Component design/selection
Initiated
April 21, 2021
Terminated
January 12, 2023

Description

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

Reason

Removing parts for safety reasons due to possible breakage.

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.

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

Quantity

87,842 UNITS