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3M™ Unitek™ Victory Series™

3M UNITEK CORPORATION · Model 068-915 · UDI-DI 00652221023902

DZD Prescription
8
510(k) clearances
25
Adverse events
4
Recalls
114
Facilities

Description

Victory Series(TM) BuccalTube Triple Convert Weld UL6 -10T/7 Off .051 Occl Hdgr 3.6 mm Hk .022 5/Pk

Recalls

DateFirmReason
2020-01-17Ormco/SybronendoThe 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
2020-01-17Ormco/SybronendoThe 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
2013-03-08Ormco/SybronendoOrmco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correct
2010-11-01Ortho Organizers IncProducts were mis-labeled as nickel free.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.