PlainRecalls
FDA Devices Moderate Class II 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

Reported: April 17, 2013 Initiated: March 8, 2013 #Z-1084-2013

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

Details

Recalling Firm
Ormco/Sybronendo
Units Affected
8210
Distribution
Worldwide Distribution - USA (nationwide) including the country of EU.
Location
Glendora, CA

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Ormco/Sybronendo. Units affected: 8210.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2013. Severity: Moderate. Recall number: Z-1084-2013.

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