FDA recall Z-1676-2021

Product

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.

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.

Key facts

Status

Terminated

Initiation date

2021-04-21

Report date

2021-06-02

Termination date

2023-01-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tokyo, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1676-2021