Z-0309-05

Titanium Orthos Bracket

Name: Z-0309-05 Titanium Orthos Bracket
Creator: Ormco Corporation
Published: 2004-11-18
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2004-11-18 / Terminated / root cause: manufacturing process

FDA source

Ormco Corporation began a recall of Titanium Orthos Bracket on 2004-11-18. The reason FDA records is "Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0309-05
Status: Terminated
Initiated: 2004-11-18
Posted: 2004-12-15
Terminated: 2005-06-17
Recalling firm: Ormco/Sybronendo
Product: Titanium Orthos Bracket
Product code: EJF Bracket, Metal, Orthodontic
Reason for recall: Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Recall letters were mailed from 11/18 thru 11/23. Letters request return of product.
Quantity in commerce: 6,257
Distribution: Nationwide and France, Luxembourg, Spain, Netherlands, Russia, Ireland, Italy, Germany, United Kingdom, Hungary, Finland, Denmark.
Product codes and lots: Part Number: 448-6111 and lot numbers:04G21, 04G83, 04J29, 04H108, 04K77. Part Number:449-6111 and lot numbers: 04G15, 04J5, 04G14, 04H141, 04H77.

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)