Home / Recalls / Ormco/Sybronendo / Z-1083-2016

Z-1083-2016 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

Recall Details

Product Type
Devices
Report Date
March 16, 2016
Initiation Date
February 8, 2016
Termination Date
August 30, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,568 units total (2,070 units in US)

Product Description

TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment

Reason for Recall

Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer package is identified as SM3 which matches the product inside.

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH

Code Information

GE15011637

Other recalls by Ormco/Sybronendo

  • 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-1257-2020 Class II — SnapLink, Ref Part No. 438-2190, L6R 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-0413-2018 Class II — Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers (December 27, 2017)
  • Z-2836-2016 Class II — Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpre (August 31, 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)