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All Recalls

Every Ormco/sybronendo Recall

Sorted by most recent. Click any recall for full details.

12 recalls
High RiskFDA
Ormco/sybronendo
SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Medical Devices·3,632,493 affected·Jan 17, 2020
High RiskFDA
Ormco/sybronendo
SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Medical Devices·3,632,493 affected·Jan 17, 2020
High RiskFDA
Ormco/sybronendo
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, T...
Medical Devices·2,189 affected·Jan 14, 2020
High RiskFDA
Ormco/sybronendo
Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intende...
Medical Devices·25,765 affected·Dec 27, 2017
High RiskFDA
Ormco/sybronendo
Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intend...
Medical Devices·179 affected·Aug 31, 2016
High RiskFDA
Ormco/sybronendo
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
Medical Devices·5,568 affected·Feb 8, 2016
High RiskFDA
Ormco/sybronendo
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Medical Devices·161 affected·Nov 4, 2015
High RiskFDA
Ormco/sybronendo
Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit...
Medical Devices·150 affected·Mar 25, 2014
High RiskFDA
Ormco/sybronendo
Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchor...
Surgical Devices·4,786 affected·Jul 12, 2013
High RiskFDA
Ormco/sybronendo
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires ...
Medical Devices·8,210 affected·Mar 8, 2013
RecallFDA
Ormco/sybronendo
The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspi...
Medical Devices·148 affected·Apr 24, 2012
High RiskFDA
Ormco/sybronendo
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Medical Devices·4,543 affected·Dec 12, 2011