Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodont

FDA device recall Z-1084-2013 · posted 2013-04-10 · Terminated

Recall details

Recalling firm

Ormco/Sybronendo

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

Action taken

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

Status

Terminated

Product code

DZD

Quantity affected

8210

Distribution

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

Date initiated

2013-03-08

Date posted

2013-04-10

Date terminated

2013-09-04

Location

Glendora, CA