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Recall Observatory FDA recall evidence

Device 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.

Z-2373-2016

July 11, 2016

Class II

Product summary

Firm
Ivoclar Vivadent, Inc.
Event
Event 74622
Status
Terminated
Classification
Class II
Quantity
US: 86 units total
Official record key
device-enforcement:Z-2373-2016

Official wording

Reason: 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.

Code information: REF/Product ID 634459: Lot UL0843; REF/Product ID 634458: Lot VL0704; REF/Product ID 634464: Lot VL0705.

Distribution pattern: Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.