Home / Recalls / Ormco/Sybronendo / Z-0413-2018

Z-0413-2018 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

FDA device recall Z-0413-2018 was initiated by Ormco/Sybronendo on December 27, 2017 and is designated Class II. Reason for recall: Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU). The recall status is terminated (terminated April 29, 2024). Affected quantity: 25,765 total.

Recall Details

Product Type
Devices
Report Date
February 7, 2018
Initiation Date
December 27, 2017
Termination Date
April 29, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25,765 total

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).

Distribution Pattern

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.

Code Information

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.

Other recalls by Ormco/Sybronendo

  • Z-1257-2020 Class II — SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2 (January 17, 2020)
  • Z-1258-2020 Class II — SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2 (January 17, 2020)
  • Z-2286-2020 Class II — Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq (January 14, 2020)
  • Z-2836-2016 Class II — Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpre (August 31, 2016)
  • Z-1083-2016 Class II — TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to f (February 8, 2016)
  • Z-0343-2016 Class II — Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. (November 4, 2015)
  • Z-1321-2014 Class II — Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449- (March 25, 2014)
  • Z-1330-2014 Class II — Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081 (March 25, 2014)
  • Z-2194-2013 Class II — Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Ve (July 12, 2013)
  • Z-1084-2013 Class II — Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracke (March 8, 2013)

FDA data resources