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Terminated

NX3 Try-In Gel. The product is used as a tooth shade resin material.

FDA Recall Z-2259-2013 · Posted 2013-09-19

Recalling FirmKerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Recall StatusTerminated
Product CodeEBF
Date Initiated2013-09-13
Date Terminated2014-02-11
Product Quantity197 units

Reason for Recall

Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.

Firm Action

Kerr Corporation initiated the voluntary recall by sending out notifications on 09/13/2013 via USPS 1st class mail. The recall notification letter, titled "URGENT: MEDICAL DEVICE RECALL", informed customer of the recall's product description, reason for recall, potential risk, instructions to customers and contact information.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution, including Nationwide in the US and the countries of Canada, Great Britain, Australia, France, Germany, Italy, Denmark, Hong Kong, China, Brazil and Saudi Arabia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001899IMPROVED TRY-IN GELSybron Dental Specialties, Inc. · 2000-08-28

Official Source

View FDA Recall →

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

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