Z-1136-2012

Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers: 454-1210, 454-0210. The intended use...

Name: Z-1136-2012 Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers: 454-1210, 454-0210. The intended use...
Creator: Ormco Corporation
Published: 2009-02-13
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2009-02-13 / Terminated / root cause: manufacturing process

FDA source

Ormco Corporation began a recall of Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers: 454-1210, 454-0210. The intended use of this device is a fixed attachment on a tooth... on 2009-02-13. The reason FDA records is "The recall was initiated because Ormco has confirmed that manufacturing error resulted in the Orthos CM Brackets being incorrectly manufactured with a torque of -9. The packaging was labeled with +9 torque; however the...". 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-1136-2012
Status: Terminated
Initiated: 2009-02-13
Posted: 2012-03-01
Terminated: 2012-03-02
Recalling firm: Ormco/Sybronendo
Product: Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers: 454-1210, 454-0210. The intended use of this device is a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Product code: EJF Bracket, Metal, Orthodontic
Reason for recall: The recall was initiated because Ormco has confirmed that manufacturing error resulted in the Orthos CM Brackets being incorrectly manufactured with a torque of -9. The packaging was labeled with +9 torque; however the brackets contained inside the packaging are actually Orthos CM Brackets with a torque of -9.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ormco Corporation sent an Urgent Field Safety Notice dated February 13, 2009, to all affected customers. The recall communication for consignees in the United States, Canada, Colombia, HongKong, Kuwait, United Arab Emirates, Mexico, Russia, South Africa and Croatia was sent on February 13, 2009 via USPS First Class Mail. The recall communication for consignees in Japan was sent on February 17, 2009. European consignees were sent recall notification on February 23, 2009. The Australian consignees and New Zealand consignees were the sent recall communication on February 25, 2009. Customers were instructed to contact Ormco Customer Care at (800) 854-1741 to receive an RMA number. The affected product should be returned to Ormco Corporation at the following address: Ormco Corporation, 1332 South Lone Hill Avenue, Glendora, CA 91740. Customers were instructed to label their return product "RECALLED PRODUCT Attention: Customer Returns". Customers were instructed to complete the enclosed Return Form and return it by fax to (909) 962-5605. For questions regarding this recall call 909-962-5600.
Quantity in commerce: 304 units
Distribution: Worldwide Distribution - USA (nationwide) and worldwide to Canada, Colombia, Hong Kong, Kuwait, United Arab Emirates, Mexico, Russia, South Africa, Croatia, Japan, France, Bulgaria, Germany, Estonia, United Kingdom, Hungary, Ireland, Italy, Netherlands, Australia, and New Zealand.
Product codes and lots: Part Number: Lot Number: 454-1210 08H599H 454-0210 08H358H, 08J174J, and 08J175J

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)