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Terminated

Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.

FDA Recall Z-0916-2010 · Posted 2010-03-02

Recalling FirmSybron Dental Specialties
Recall StatusTerminated
Product CodeEBF
Date Initiated2009-02-23
Date Terminated2012-03-19
Product Quantity442

Reason for Recall

Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card.

Firm Action

Kerr Corporation issued a letter dated February 23, 2009. Users were informed of the affected product and instructed on proper return. For further information, contact Kerr Customer Care at 1-800-537-7123.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082671HERCULITE ULTRASybron Dental Specialties · 2008-12-11

Official Source

View FDA Recall →

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

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