Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2836-2016 — 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.

U.S. FDA — Device Enforcement · United States · 2016-08-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2836-2016
Date of alert
2016-08-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ormco/Sybronendo
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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