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
This recall has been terminated (originally issued April 10, 2013).
- Company
- Ormco/Sybronendo
- Recall Initiated
- March 8, 2013
- Posted
- April 10, 2013
- Terminated
- September 4, 2013
- Recall Number
- Z-1084-2013
- Quantity
- 8210
- Firm Location
- Glendora, CA
- Official Source
- View on FDA website ↗
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
Worldwide Distribution - USA (nationwide) including the country of EU.
Lot / Code Info
Part Number 438-0184 Lot Number 051063597
Root Cause
Packaging
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.