Home / Recalls / Ormco/Sybronendo / Z-2286-2020

Z-2286-2020 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

Recall Details

Product Type
Devices
Report Date
June 17, 2020
Initiation Date
January 14, 2020
Termination Date
February 10, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,189 units

Product Description

Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

Reason for Recall

The bracket torque was mislabeled on the packaging.

Distribution Pattern

Worldwide Distribution: US (nationwide) to states of: AR, AZ, FL, GA, IL, LA, MS, NC, NE, NJ, NY, PA, TN, and TX. Foreign distribution was made to Belgium, Czech Republic, France, Germany, Israel, Italy, Kuwait, Latvia, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, South Africa, Spain, Switzerland, Tunisia, United Arab Emirates, and United Kingdom.

Code Information

Lot number 031902599

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-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-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)