Recall Z-1321-2014— Ormco/Sybronendo
Class II · Terminated
Class II FDA medical device recall by Ormco/Sybronendo, initiated 2014-03-25, terminated 2014-10-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Ormco/Sybronendo
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-25
- Terminated
- 2014-10-27
- Firm location
- Glendora, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.