Z-1321-2014Class II

Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A...

Name: Z-1321-2014 Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A...
Creator: Ormco/Sybronendo
Published: 2014-03-25
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2014-03-25 / Terminated

FDA source

Ormco/Sybronendo began a recall of 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... on 2014-03-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1321-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-25
Posted: 2014-04-02
Terminated: 2014-10-27
Recalling firm: Ormco/Sybronendo
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.
Product code: EJF Bracket, Metal, Orthodontic
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.
FDA root cause: Other
Action: Recall notification letters sent to all affected consignees via 1st class mail on March 24, 2014. The consignees are instructed to complete the Return Form and have the option to return any affected product in their inventory to Ormco Corporation. The letter is dated "March 24, 2014" and titled: "URGENT: MEDICAL DEVICE RECALL". The letter informed customers of the recall, reason for recall, product description with part number and lot number, instructions to follow, and contact information. The letter was accompanied by a "Recall Return/Acknowledgement Form".
Quantity in commerce: 150 units
Distribution: US and Canada.
Product codes and lots: Part Number 449-6212, Lot Number 121359169.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1321-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1321-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-02

Product code EJF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)