Ormco/Sybronendo recalls Elements Obturation Units (EOU) used with Buchanan Heat Pluggers due to possible overheating during dental procedures. Affected units include specific part numbers and serial numbers.
Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
Ormco/Sybronendo is recalling Elements Obturation Units (EOU) that are used with Buchanan Heat Pluggers for dental root canal treatments. The EOU and Heat Pluggers may overheat during use, potentially causing injury to the patient or dentist.
The EOU and Buchanan Heat Pluggers may overheat when used together during dental root canal treatments. This overheating could cause burns or tissue damage to the patient or dentist if not properly monitored.
Dentists and dental clinics using the Elements Obturation Unit (EOU) with Buchanan Heat Pluggers are affected. The risk is highest for those using the devices in dental procedures where heat is applied to teeth.
Check for the Elements Obturation Unit (EOU) with part number 973-0322 or Buchanan Heat Pluggers with part numbers 952-0004 through 952-0007 and 973-0219. All serial numbers of these products are included in the recall.
Verify the serial numbers of the Elements Obturation Unit (EOU) and Buchanan Heat Pluggers to confirm they are affected by the recall.
Reach out to Ormco/Sybronendo for guidance on next steps if your devices are affected.
The Elements Obturation Unit (EOU) has part number 973-0322, and Buchanan Heat Pluggers have part numbers 952-0004, 952-0003, 952-0005, 952-0006, 952-0007, 952-0031, and 973-0219.
Check the serial numbers of your Elements Obturation Unit (EOU) and Buchanan Heat Pluggers; all affected units are included in the recall.
Contact Ormco/Sybronendo for guidance on next steps, as the recall does not specify a specific action beyond checking serial numbers.
We’ve drafted a message you can send Ormco/Sybronendo to request your refund or repair — edit it as you like.
Subject: Recall Z-0413-2018 — Ormco/Sybronendo Ormco/Sybronendo Hello, I own a Ormco/Sybronendo that is covered by recall Z-0413-2018 from Ormco/Sybronendo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
