Z-1084-2013 Class II Terminated
FDA device recall Z-1084-2013 was initiated by Ormco/Sybronendo on March 8, 2013 and is designated Class II. 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 p… The recall status is terminated (terminated September 4, 2013). Affected quantity: 8210.
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2013
- Initiation Date
- March 8, 2013
- Termination Date
- September 4, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8210
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
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the country of EU.
Code Information
Part Number 438-0184 Lot Number 051063597