PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 2, 2021 Initiated: April 21, 2021 #Z-1676-2021

Product Description

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

Reason for Recall

Removing parts for safety reasons due to possible breakage.

Details

Recalling Firm
Dentech Corp.
Units Affected
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, Sweden, Netherland, France, Poland, Slovenia, Bulgaria, Norway and Romania.
Location
Tokyo, N/A

Frequently Asked Questions

What product was recalled?
Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.. Recalled by Dentech Corp.. Units affected: 87,842 UNITS.
Why was this product recalled?
Removing parts for safety reasons due to possible breakage.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 2, 2021. Severity: Moderate. Recall number: Z-1676-2021.