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Terminated

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

FDA Recall Z-1084-2013 · Posted 2013-04-10

Recalling FirmOrmco/Sybronendo
Recall StatusTerminated
Product CodeDZD
Date Initiated2013-03-08
Date Terminated2013-09-04
Product Quantity8210

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

Firm Action

Ormco sent an Urgent Medical Device Recall letter dated March 8, 2013 to all affected customers, via USPS 1st class mail. The letter identified the affected product, problem and actions to be taken. The consignees were instructed to complete the Return Form and return any affected product identified in stock. For questions contact Ormco Customer Care.

Root Cause

Packaging

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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