Home / Recalls / Medical Devices
Ivoclar Vivadent, Inc. recalls OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/P
Recalled August 17, 2016 · FDA recall Z-2373-2016 · Ivoclar Vivadent
Hazard
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. · FDA Class II
Units
US: 86 units total
Sold at
Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
Description
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.
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 amalgam.
Manufacturer(s)
Ivoclar Vivadent, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →