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U.S. Department of Health and Human Services

Class 2 Device Recall OptraPol Polishing Discs

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  Class 2 Device Recall OptraPol Polishing Discs see related information
Date Initiated by Firm July 11, 2016
Create Date August 09, 2016
Recall Status1 Terminated 3 on September 22, 2017
Recall Number Z-2373-2016
Recall Event ID 74622
Product Classification Disk, abrasive - Product Code EHJ
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.
Code Information REF/Product ID 634459: Lot UL0843;  REF/Product ID 634458: Lot VL0704;  REF/Product ID 634464: Lot VL0705. 
Recalling Firm/
Manufacturer		 Ivoclar Vivadent, Inc.
175 Pineview Dr
Amherst NY 14228-2231
For Additional Information Contact Donna Marie Hartnett
716-691-2260
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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