FDA Device recall Z-1076-2013
Kerr Maxcem Elite, self-etch/self-adhesive resin cement
- FDA Device
- Class II
- terminated
- Published 2013-04-17
On 2013-04-17 the FDA classified a Class II recall of Kerr Maxcem Elite, self-etch/self-adhesive resin cement by Kerr Pentron, citing kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product coul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1076-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-22 |
| Published | 2013-04-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Kerr Pentron |
| Distribution | US |
Product
Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.
Reason
Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly.
Identifiers
| code_info | 34417 KIT- MAXCEM ELITE INTRO 2-4662052 4672087 4694484 4698107 4710901 4719936 4725775 4725776 34418 KIT - MAX…34417 KIT- MAXCEM ELITE INTRO 2-4662052 4672087 4694484 4698107 4710901 4719936 4725775 4725776 34418 KIT - MAXCEM ELITE BULK-4706738 4656479 4656480 4666810 4666811 4666813 4668612 4709788 4710900 4712887 4725780 4729919 4734053 4744195 SYRINGE LOT NUMBERS 34417 & 34418 SYRINGE- MAXCEM ELITE CLEAR Individually affected syringes within Kits listed above-4663716 4663717 4690551 4690552 4704821 4728088 4741721 33872 REFILL- MAXCEM ELITE CLEAR-4664825 4669840 4669841 4672089 4676812 4676815 4678974 4678975 4690548 4690549 4690550 4702597 4710904 4710905 4718097 4720553 4720555 4720558 4720560 4720562 4720563 4720564 4720565 33873 REFILL- MAXCEM ELITE WHITE-4681749 4699954 4704804 4720556 4720567 4720568 4720569 4720573 4720574 4720575 33874 -REFILL- MAXCEM ELITE WHITE OPAQUE-4720576 4720577 4720578 4720579 4720580 33875-REFILL- MAXCEM ELITE YELLOW -4652147 4696832 4720198 33876 -REFILL- MAXCEM ELITE BROWN -4710907 47 |
|---|
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-1076-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.