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.
This recall has been terminated (originally issued December 27, 2017).
- Company
- Ormco/Sybronendo
- Recall Initiated
- December 27, 2017
- Terminated
- April 29, 2024
- Recall Number
- Z-0413-2018
- Quantity
- 25,765 total
- Firm Location
- Glendora, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
Distribution
USA (nationwide) distributed to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to Armenia, Australia, Canada, Chile, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Malaysia, Mexico, Netherlands, Pakistan, Panama, Philippines, Singapore, South Korea, Switzerland, Thailand, United Kingdom, Vietnam.
Lot / Code Info
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, 973-0219 (hot pulp test tip). All serial numbers of the EOU and respective Buchanan Heat Pluggers are included in the recall.
Root Cause
Under Investigation by firm
Action Taken
Sybron Endo sent an Urgent: Medical Device Recall letter dated December 27, 2017. Customers were informed that Sybron Endo was still evaluating the root cause and would provide additional instructions once the root cause is determined. Distributors were asked to cease distributing any Elements Obturation Units (EOU), confirm if any are in inventory, return any affected devices, provide the notification to customers if further distributed, return any affected devices received from customers, and complete and return the acknowledgement form. Customers were instructed to examine current inventory for affected product, check the heat plugger to see if the NiTi icon appears and/or the tip turns glowing red, if it does do not use the heat plugger and return it to Sybron Endo, and complete and return the acknowledgement form. For further questions, please call the Customer Care department at (800) 537-7123.