Ivoclar Vivadent, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2373-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 11, 2016

Date Posted: August 17, 2016

Recall Number: Z-2373-2016

Event ID: 74622

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.

Status: Terminated

Product Quantity: US: 86 units total

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.

Voluntary or Mandated:

Voluntary: Firm initiated