Ivoclar Vivadent Recalls OptraPol Dental Polishing Discs Due to Breakage
Ivoclar Vivadent is recalling OptraPol polishing discs and cups because parts break away during use. The recall covers 86 units distributed in 16 states.
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 involves a medical device where parts break away during use, posing a risk of harm to patients or operators, but no injuries or illnesses have been reported.
Plain-English summary
Ivoclar Vivadent, Inc. is recalling OptraPol Polishing Discs, OptraPol Refill Cups, OptraPol Refill Small Flames, and OptraPol Assortments. The recall involves 86 units total, including specific lot numbers UL0843, VL0704, and VL0705. These products are a one-step polishing system for dental composites and amalgam.
The recall was initiated because parts of the OptraPol cup and Small Flame break away after a few seconds of polishing with moderate force. Two complaints were filed regarding the OptraPol products, claiming that the abrasive polishers wear faster than expected.
The affected products were distributed in California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Nevada, New York, Ohio, Pennsylvania, Texas, and Washington. Consumers and dental professionals should stop using these products and contact Ivoclar Vivadent for instructions on return or replacement.
The recalled product
- Product
- OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalga
- Manufacturer
- Ivoclar Vivadent, Inc.
- Hazard
- Affected units
- 86
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 (3)
- REF/Product ID 634459: Lot UL0843
- REF/Product ID 634458: Lot VL0704
- REF/Product ID 634464: Lot VL0705.
Distribution
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