Home / Recalls / Ormco/Sybronendo / Z-1084-2013

Z-1084-2013 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

Recall Details

Product Type
Devices
Report Date
April 17, 2013
Initiation Date
March 8, 2013
Termination Date
September 4, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8210

Product Description

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

Reason for Recall

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

Distribution Pattern

Worldwide Distribution - USA (nationwide) including the country of EU.

Code Information

Part Number 438-0184 Lot Number 051063597

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