Reported Aug 17, 2016 · Terminated
OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10:…
Ivoclar Vivadent, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ivoclar Vivadent, Inc. · 175 Pineview Dr · Amherst, NY · 14228-2231
Is this the product you have?
- OptraPol Polishing Discs
- Rx ONLYOptraPol
- Refill Cup /10REF/Product ID 634459
- OptraPol Refill Small Flame/10REF/Product ID 634458
- OptraPol AssortmentREF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam
- Lot codes and dates
- REF/Product ID 634459Lot UL0843
- REF/Product ID 634458Lot VL0704
- REF/Product ID 634464Lot VL0705
- Amount recalled
- US: 86 units total
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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