Home / Recalls / Ormco/Sybronendo / Z-1257-2020

Z-1257-2020 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

Recall Details

Product Type
Devices
Report Date
February 26, 2020
Initiation Date
January 17, 2020
Termination Date
September 30, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,632,493 brackets

Product Description

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

Reason for Recall

The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months.

Distribution Pattern

US:AK,AL,AR,AZ,CA,CO,CN,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,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV,WY OUS: Argentina, Australia, Barbados, Bahamas, Bolivia, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Hong Kong, Indonesia, Japan, Cambodia, Korea, Cayman Islands, Sri Lanka, Myanmar, Mexico, Malaysia, Netherlands, Nepal, Panama, Philippines, Paraguay, Russian Federation, Singapore, Thailand, Taiwan, Uruguay, Viet Nam, South Africa

Code Information

All Lots UDI #s: 00889989002652 & 00889989002669

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-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-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)