Z-2373-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 17, 2016
- Initiation Date
- July 11, 2016
- Termination Date
- September 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 86 units total
Product Description
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 amalgam.
Reason for Recall
After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected.
Distribution Pattern
Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
Code Information
REF/Product ID 634459: Lot UL0843; REF/Product ID 634458: Lot VL0704; REF/Product ID 634464: Lot VL0705.