OptraPol Polishing Discs — Class II medical device recall Z-2373-2016
Terminated recall by Ivoclar Vivadent, Inc., reported 2016-08-17, distributed in CA, FL, GA, IA, IL, IN, KS, KY…. After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Sm
| Recall number | Z-2373-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ivoclar Vivadent, Inc., Amherst, NY, United States |
| Recall initiated | 2016-07-11 |
| Classified | 2016-08-09 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2017-09-22 |
| Distributed | CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, WA |
| Quantity | 86 units |
| Lot numbers | UL0843, VL0704, 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 Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2373-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.