FDA-Device2013-04-17Class II
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
Ormco/Sybronendo
Hazard
Ormco 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 correctly identifies the product as gingival (0¿) offset brackets, but actually contains distal (10¿) offset brackets. Use of the affected product may cause unintended rotation of the molars. Although reversible, a delay in
Sold states
Worldwide Distribution - USA (nationwide) including the country of EU.
Affected count
8210
Manufactured in
1332 S Lone Hill Ave, Glendora, CA, United States
Products
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1084-2013Don't want to check this manually?
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