Ormco/Sybronendo: Medical Device Recall in 2014 - (Recall #: Z-1321-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 25, 2014

Date Posted: April 9, 2014

Recall Number: Z-1321-2014

Event ID: 67861

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.

Status: Terminated

Product Quantity: 150 units

Code Information:

Part Number 449-6212, Lot Number 121359169.

Distribution Pattern:

US and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated