Recall Z-0413-2018— Ormco/Sybronendo
Class II · Terminated
Class II FDA medical device recall by Ormco/Sybronendo, initiated 2017-12-27, terminated 2024-04-29. It names one FDA 510(k) clearance: K031664. 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 cauterization and coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation.. Reason: Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU)..
- Recalling firm
- Ormco/Sybronendo
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-27
- Terminated
- 2024-04-29
- Firm location
- Glendora, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
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 cauterization and coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation.
Reason for recall
Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
Data sourced from openFDA. This site is unofficial and independent of the FDA.