Recall Z-2836-2016— Ormco/Sybronendo

Name: FDA recall Z-2836-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-31

Class II · Terminated

Class II FDA medical device recall by Ormco/Sybronendo, initiated 2016-08-31, terminated 2017-09-01. It names one FDA 510(k) clearance: K010940. 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..

Recalling firm: Ormco/Sybronendo
Classification: Class II
Status: Terminated
Initiated: 2016-08-31
Terminated: 2017-09-01
Firm location: Glendora, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K010940 — SEALAPEX 4Sybron Dental Specialties, Inc.·cleared 2001-06-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.