Recall Z-0413-2018 ยท EKR Plugger, Root Canal, Endodontic
Ormco/Sybronendo
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 Ext
| Date | Dec 27, 2017 |
| Status | Terminated |
| Reason | Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU). |
| Root cause | Under Investigation by firm |
| Action | 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 in |
| Quantity | 25,765 total |
| 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, Canad |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031664 | ELEMENTS OBTURATION UNIT Sybron Endo/Analytic, Apr 28, 2004 |