NX3 Try-In Gel — Class II medical device recall Z-2259-2013
Terminated recall by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, reported 2013-09-25, distributed nationwide. Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syring
| Recall number | Z-2259-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, Orange, CA, United States |
| Recall initiated | 2013-09-13 |
| Classified | 2013-09-19 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2014-02-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CN, DE, DK, FR, GB, HK, IT, SA |
| Quantity | 197 units |
| Reason classes | labeling |
| Lot numbers | 4580333, 4584609 |
| Model numbers | 33660 |
Product
NX3 Try-In Gel. The product is used as a tooth shade resin material.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2259-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.