Ormco/Sybronendo Recalls Elements Obturation Units and Buchanan Heat Pluggers
Ormco/Sybronendo is recalling 25,765 Elements Obturation Units and Buchanan Heat Pluggers because the pluggers may overheat during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of overheating which can cause burn injuries, but the source text does not report any actual injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ormco/Sybronendo is recalling 25,765 Elements Obturation Units (EOU) and associated Buchanan Heat Pluggers. The recall is due to a risk that the Buchanan Heat Pluggers may overheat while being used with the EOU. The EOU is an endodontic root canal plugger intended for dental use to provide continuous heat at the tip of a dental instrument for testing tooth response, tissue cauterization, and backfilling gutta percha during root canal treatment.
The affected products include the Elements Obturation Unit (Part Number 973-0322) and specific Buchanan Heat Pluggers (Part Numbers 952-0004, 952-0003, 952-0005, 952-0006, 952-0007, 952-0031, and 973-0219). All serial numbers of these units and pluggers are included in the recall. The products were distributed nationwide in the United States and internationally to multiple countries including Canada, the United Kingdom, and Australia.
Dental professionals and patients who have used or possess these devices should stop using them immediately. Users should contact Ormco/Sybronendo for instructions on how to return the devices or obtain a replacement, as directed by the recalling firm.
The recalled product
- Product
- Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue…
- Manufacturer
- Ormco/Sybronendo
- Hazard
- Affected units
- 25,765
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Part Number for Elements Obturation Unit (EOU): 973-0322
- and Part Numbers for the Buchanan Heat Pluggers: 952-0004
- 952-0003
- 952-0005
- 952-0006
- 952-0007
- 952-0031
Distribution
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