Ormco/Sybronendo: Medical Device Recall in 2013 - (Recall #: Z-1084-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: March 8, 2013

Date Posted: April 17, 2013

Recall Number: Z-1084-2013

Event ID: 64749

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

Status: Terminated

Product Quantity: 8210

Code Information:

Part Number 438-0184 Lot Number 051063597

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated