Recall Z-1544-2013— Ormco/Sybronendo

Name: FDA recall Z-1544-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-17

Class II · Terminated

Class II FDA medical device recall by Ormco/Sybronendo, initiated 2013-01-17, terminated 2013-11-07. It names one FDA 510(k) clearance: K031664. Product: SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.. Reason: A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord..

Recalling firm: Ormco/Sybronendo
Classification: Class II
Status: Terminated
Initiated: 2013-01-17
Terminated: 2013-11-07
Firm location: Glendora, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K031664 — ELEMENTS OBTURATION UNITSybron Endo/Analytic·cleared 2004-04-28

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

SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.

Reason for recall

A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.

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