Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical: Medical Device Recall in 2013 - (Recall #: Z-2259-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: September 13, 2013
Date Posted: September 25, 2013
Recall Number: Z-2259-2013
Event ID: 66276
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.

Status: Terminated
Product Quantity: 197 units
Code Information:

Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.

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.

Voluntary or Mandated:

Voluntary: Firm initiated