Dentech Corp. Recalls Rubber Dam Clamps Due to Possible Breakage
Dentech Corp. is recalling 87,842 units of KSK Rubber Dam Clamps because they may break during use. The recall covers units distributed in the US and worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves possible breakage of a medical device during use, which presents a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Dentech Corp. is recalling 87,842 units of KSK Rubber Dam Clamps. These dental instruments are used to prevent contamination by saliva and moisture during dental treatment. The recall was initiated for safety reasons due to a possibility of the parts breaking.
The affected products were distributed nationwide in the United States, specifically in California, Minnesota, Kentucky, and Washington. Additionally, the products were distributed worldwide to numerous countries including Russia, Libya, Moldova, China, Egypt, India, Canada, Guatemala, Iraq, Saudi Arabia, Australia, Ukraine, Israel, Indonesia, Malaysia, the UK, Singapore, South Korea, Georgia, Taiwan, Lithuania, Greece, Sweden, the Netherlands, France, Poland, Slovenia, Bulgaria, Norway, and Romania.
The recall involves multiple product codes (01012912, 01014912, 01019912, 01012913, 01014913, 01019913, 01012026, 01014026, and 01019026) and a large number of specific lot numbers. Consumers and dental professionals should check their inventory against the provided lot numbers and stop using the affected clamps.
The recalled product
- Product
- Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
- Manufacturer
- Dentech Corp.
- Hazard
- Affected units
- 87,842
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code 01012912
- no12A Lot Numbers: 190627004
- 1812L014
- 190708016
- 190701018
- 190712065
- 190712043
- 190805016
- 190730025
- 190731036
- 190829013
- 190903026
- 190815021
- 190925016
- 191017004
- 191009022
- 191016040
- 191025003
- 190816010
- 190816060
Distribution
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