FDA Device recall Z-2259-2013
NX3 Try-In Gel
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of NX3 Try-In Gel by Kerr Pentron, citing 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 mate….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2259-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-13 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Kerr Pentron |
| Distribution | US |
Product
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Reason
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.
Identifiers
| code_info | Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2259-2013%22
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