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.
FDA Recall Z-2373-2016 · Posted None
Recalling FirmIvoclar Vivadent, Inc.
Recall StatusTerminated
Product CodeEHJ
Date Initiated2016-07-11
Date Terminated2017-09-22
Product QuantityUS: 86 units total
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.
Firm Action
URGENT MEDICAL DEVICE RECALL Letter (dated 7/11/2016) and Response Form were sent to customers on 7/11/2016 via Certified Mail, Return Receipt, Requested. The letter instructs customers to notify their customers of the recall if the product had been distributed and to return the product to Ivoclar Vivadent. For questions, please contact Ivoclar Vivadent Customer Service at 1-800-533-6825.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.