Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
FDA Recall Z-0665-2018 · Posted None
Recalling FirmIvoclar Vivadent, Inc.
Recall StatusTerminated
Product CodeEBF
Date Initiated2017-08-03
Date Terminated2018-08-28
Product Quantity2,153 units
Reason for Recall
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Firm Action
The firm sent letters to consignees on August 3, 2017 instructing them to segregate the recalled product and arrange for a replacement of stock.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.