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Recall Observatory FDA recall evidence

Device 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.

Z-1321-2014

March 25, 2014

Class II

Product summary

Firm
Ormco/Sybronendo
Event
Event 67861
Status
Terminated
Classification
Class II
Quantity
150 units
Official record key
device-enforcement:Z-1321-2014

Official wording

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.

Code information: Part Number 449-6212, Lot Number 121359169.

Distribution pattern: US and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.