FDAFDA · Food and drugs·Recall number Z-1321-2014
Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Published April 9, 2014 · Recall initiated: March 25, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ormco/Sybronendo
- Distributor
- US and Canada.
- Lot
- Part Number 449-6212, Lot Number 121359169.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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