FDA Device recall Z-2836-2016
Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin
- FDA Device
- Class II
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin by Ormco Sybronendo, citing sybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2836-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-31 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ormco Sybronendo |
| Distribution | US |
Product
Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
Reason
SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11.
Identifiers
| code_info | lot # 5-1310 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2836-2016%22
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