Home / Recalls / Ormco/Sybronendo / Z-1545-2013

Z-1545-2013 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

FDA device recall Z-1545-2013 was initiated by Ormco/Sybronendo on January 17, 2013 and is designated Class II. 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 Replacemen… The recall status is terminated (terminated November 7, 2013). Affected quantity: 3615 unit total.

Recall Details

Product Type: Devices
Report Date: June 26, 2013
Initiation Date: January 17, 2013
Termination Date: November 7, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3615 unit total

Product Description

SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan 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.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Australia, Azerbaijan, Belgium, Canada, China, Cyprus, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Italy, Japan, Kuwait, Latvia, Lebanon, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

Code Information

Lot/Serial Numbers: 3757349, 4220920, 4304917, 4367699, 436513, 4445719, 4458262, 4522605, 4581118, 4724407, 4730212

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