Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 recall
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…
Why was Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number 438-0184 Lot Number 051063597
- Product
- 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…
- Recalling firm
- Ormco/Sybronendo
- Quantity
- 8210
- Distribution
- Worldwide Distribution - USA (nationwide) including the country of EU.
- Recall date
- April 17, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)