Home / Recalls / Ormco/Sybronendo / Z-1321-2014

Z-1321-2014 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

Recall Details

Product Type
Devices
Report Date
April 9, 2014
Initiation Date
March 25, 2014
Termination Date
October 27, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
150 units

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.

Distribution Pattern

US and Canada.

Code Information

Part Number 449-6212, Lot Number 121359169.

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