Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2259-2013 — NX3 Try-In Gel. The product is used as a tooth shade resin material.

U.S. FDA — Device Enforcement · United States · 2013-09-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2259-2013
Date of alert
2013-09-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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