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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

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
Recall Number Z-1084-2013
Classification Class II
Code Info Part Number 438-0184 Lot Number 051063597
Product Distributed Qty 8210
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 treatment could occur.

Event Detail

Event Id 64749
Product Type Devices
Status Ongoing
Recalling Firm Ormco/Sybronendo
City Glendora
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) including the country of EU.