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Recall Observatory FDA recall evidence

Device product

Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

Z-0665-2018

August 03, 2017

Class III

Product summary

Firm
Ivoclar Vivadent, Inc.
Event
Event 79064
Status
Terminated
Classification
Class III
Quantity
2,153 units
Official record key
device-enforcement:Z-0665-2018

Official wording

Reason: 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.

Code information: Batch: V35109 Exp. date: 01.10.2020; Batch: V40817 Exp. date: 13.11.2020; Batch: V48597 Exp. date: 30.12.2020; Batch: V48938 Exp. date: 31.12.2020 Batch: W12251 Exp. date: 31.03.2021

Distribution pattern: US and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.