NX3 Try-In Gel. The product is used as a tooth shade resin material.
FDA device recall Z-2259-2013 · posted 2013-09-19 · Terminated
Recall details
- Recalling firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- EBF
- Quantity affected
- 197 units
- Distribution
- 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.
- Date initiated
- 2013-09-13
- Date posted
- 2013-09-19
- Date terminated
- 2014-02-11
- Location
- Orange, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMPROVED TRY-IN GEL (K001899) | Sybron Dental Specialties, Inc. | 2000-08-28 |