Device product
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
Z-1084-2013
Product summary
- Firm
- Ormco/Sybronendo
- Event
- Event 64749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8210
- Official record key
device-enforcement:Z-1084-2013
Official wording
Reason: 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
Code information: Part Number 438-0184 Lot Number 051063597
Distribution pattern: Worldwide Distribution - USA (nationwide) including the country of EU.
Derived failure modes
-
Labeling or packaging
packaging error