URGENT: MEDICAL DEVICE RECALL Elements Obturation Unit with Buchanan Heat Pluggers
13 March 2018
Dentists have been alerted that the Sybron Endo Corporation have issued an initial voluntary medical device recall for the Buchanan Heat Pluggers, ONLY when used with the Elements Obturation Unit (EOU).
Sybron Endo have become aware that on rare occasions the heat pluggers tips have been found to overheat and may exceed 700⁰C upon activation in any operating mode. When this occurs, the screen will indicate NiTi and the tip will begin glowing red shortly after activation.
While long term health consequences due to the increased heat have not been confirmed a rise in temperature in or around the root canal could cause damage to surrounding tissues.
A 10⁰C heat rise is the limit for preserving surrounding dental tissues, which depending on technique used, the affected pluggers could pose this risk.
However, they believe the probability of health consequences is remote due to a lack of clinical reports or complaints of harm to patients after nine years of clinical use of the EOU in the field.
They are recommending:
- Reference the EOU IFU
- After turning on the device, select the desired mode, activate the System B handpiece and observe the heat plugger tip and EOU console screen for 3 seconds
- IF in three seconds, the NiTi icon appears on screen, and/or the heat plugger tip turns glowing red, the tip shouldn’t be used and should be replaced by a new one.
- Repeat the three second check on the new tip
- If the NiTi icon and glowing tip DO NOT appear, then the tip is safe to use
- Return any affected heat plugger(s) and call customer care for RMA