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Recall Observatory FDA recall evidence

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

March 08, 2013

Class II

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

    reason.labeling_packaging · v1.0.0

    packaging error