FDAClass IIAugust 17, 2016

OptraPol Polishing Discs recall

OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol…

Why was OptraPol Polishing Discs 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol…
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
US: 86 units total
Distribution
Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
Recall date
August 17, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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