Z-1545-2013Class II

SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill...

Name: Z-1545-2013 SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill...
Creator: Ormco/Sybronendo
Published: 2013-01-17
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2013-01-17 / Terminated / root cause: labeling and UDI

FDA source

Ormco/Sybronendo began a recall of 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... on 2013-01-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1545-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-17
Posted: 2013-06-14
Terminated: 2013-11-07
Recalling firm: Ormco/Sybronendo
Product: 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.
Product code: EKR Plugger, Root Canal, Endodontic
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm SybronEndo sent a "FIELD CORRECTION ACTION" letter dated January 30, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were requested to review and determine if they have any of the affected equipment in their inventory; Note: the equipment itself has not been modified in any way, and therefore there is no change in the performance; customers should continue to use the equipment in the same manner they have in the past:; Note: SynbronEndo has enclosed the cautionary label along with instructions for proper placement of the affected equipment; the customers should apply the enclosed cautionary statement label to Elements Obturation Unit and/or Replacement AC Power Cord as per instructions and complete and return the FIELD CORRECTION ACKNOWLEDGEMENT FORM ,whether or not they have any affected equipment in their inventory, via Fax to: 909-962-5605. For questions regarding this recall call 714-516-7602. Note: If you are an authorized SybronEndo international distributor, we request that you identify those customers that may have been shipped the affected lots of equipment and contact these customers to inform them of the issue within forty-eight (48) hours of receipt of this notification. If you have any questions, contact SybronEndo Customer Care at 1-800-346-3636.
Quantity in commerce: 3615 unit total
Distribution: 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.
Product codes and lots: Lot/Serial Numbers: 3757349, 4220920, 4304917, 4367699, 436513, 4445719, 4458262, 4522605, 4581118, 4724407, 4730212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1545-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1544-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-26	2013-06-14
Z-1545-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-26	2013-06-14

Product code EKR

K031664Class IElements Obturation UnitSybron Endo/Analytic / cleared 2004-04-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)