Recall Z-2259-2013 ยท EBF Material, Tooth Shade, Resin
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
NX3 Try-In Gel. The product is used as a tooth shade resin material.
| Date | Sep 19, 2013 (initiated Sep 13, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Mixed-up of materials/components |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001899 | IMPROVED TRY-IN GEL Sybron Dental Specialties, Inc., Aug 28, 2000 |