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Terminated

Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503

FDA Recall Z-0667-2018 · Posted None

Recalling FirmIvoclar Vivadent, Inc.
Recall StatusTerminated
Product CodeEBF
Date Initiated2017-08-03
Date Terminated2018-08-28
Product Quantity1,244 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.

K884588HELIOMOLAR(R) DENTAL RESTORATIVEWilliams Dental Co., Inc. · 1989-01-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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