Ormco/Sybronendo recalls

Ormco/Sybronendo has 16 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 17 Jun 2020.

Total recalls16since 2012
Last 12 months0reported
Class I00% of total
Ongoing0latest 17 Jun 2020

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 15 94%Class III 1 6%

By year

All ormco/sybronendo recalls, newest first

16 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIOrmco Damon Q2 Orthodontic Metal Bracket recalled by Ormco/SybronendoOrmco/SybronendoLabeling ErrorsNationwide
DeviceCLASS IISnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022 recalledOrmco/SybronendoDevice Malfunction51 states
DeviceCLASS IISnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022 recalledOrmco/SybronendoDevice Malfunction51 states
DeviceCLASS IIElements Obturation Unit (EOU) used recalled by Ormco/SybronendoOrmco/SybronendoOtherNationwide
DeviceCLASS IISealapex Xpress recalled by Ormco/SybronendoOrmco/SybronendoPackaging DefectsNationwide
DeviceCLASS IITF Adaptive Gutta Percha Point Size SM3 recalled by Ormco/SybronendoOrmco/SybronendoPackaging DefectsNationwide
DeviceCLASS IICopper NiTi Preformed Archwires recalled by Ormco/SybronendoOrmco/SybronendoTemperature AbuseNationwide
DeviceCLASS IITitanium Orthos Brackets, an orthodontic bracket recalledOrmco/SybronendoOtherCA
DeviceCLASS IISpirit MB Bracket, UR Central +14T +5A.018 recalled by Ormco/SybronendoOrmco/SybronendoOtherCA
DeviceCLASS IIVector TAS Screw recalled by Ormco/SybronendoOrmco/SybronendoDevice MalfunctionNationwide
DeviceCLASS IISybronEndo Elements Obturation Unit recalled by Ormco/SybronendoOrmco/SybronendoOtherNationwide
DeviceCLASS IISybronEndo Replacement AC Power Cord, US Elements Obturation recalledOrmco/SybronendoOtherNationwide
DeviceCLASS IIBracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 recalledOrmco/SybronendoPackaging DefectsNationwide
DeviceCLASS IISybron Endo Lightspeed: LSX Files, Part Numbers recalledOrmco/SybronendoOtherCA
DeviceCLASS IIVector TAS Modular Driver, a manual driver recalled by Ormco/SybronendoOrmco/SybronendoSterilityNationwide
DeviceCLASS IIIThe name of the device is Damon 3MX Bicuspid Bracket recalledOrmco/SybronendoOtherNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.