Reported Apr 17, 2013 · Terminated
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in…
Ormco/Sybronendo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ormco/Sybronendo · 1332 S Lone Hill Ave · Glendora, CA · 91740-5339
Is this the product you have?
- Bracket Buccal Tube U7L DB/UL22
- Roth MT HK 0/-14/0 Product UsageBracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
- Lot codes and dates
- Part Number 438-0184 Lot Number 051063597
- Amount recalled
- 8210
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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