CLASS II Device recall · Reported 26 Jun 2013 · FDA Enforcement Report
SybronEndo Replacement AC Power Cord, US Elements Obturation recalled
Ormco/Sybronendo is recalling SybronEndo Replacement AC Power Cord, US Elements Obturation, distributed nationwide in the US. The recall was initiated on 17 Jan 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1545-2013
- FDA event ID
- 64216
- Recalling firm
- Ormco/Sybronendo, Glendora, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jan 2013
- FDA classified
- 14 Jun 2013
- Reported
- 26 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 17 Jan 2013 | Recall initiated by company | |
| 14 Jun 2013 | Classified by FDA | +148 days |
| 26 Jun 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is SybronEndo Replacement AC Power Cord, US Elements Obturation recalled?
Yes. Ormco/Sybronendo recalled SybronEndo Replacement AC Power Cord, US Elements Obturation on 17 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-1545-2013.
Why was it recalled?
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.
Which lots are affected?
Lot/Serial Numbers: 3757349, 4220920, 4304917, 4367699, 436513, 4445719, 4458262, 4522605, 4581118, 4724407, 4730212
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ormco/Sybronendo
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|---|---|---|---|---|---|
| Device | CLASS II | Ormco Damon Q2 Orthodontic Metal Bracket recalled by Ormco/Sybronendo | Ormco/Sybronendo | Labeling Errors | Nationwide |
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