Retiro De Equipo (Recall) de Device Recall Orthos CM Bracket, Orthodontic Metal Bracket,

Recall

61221

Class 3

Z-1136-2012

2009-02-13

2012-03-01

Terminated

United States

2012-03-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107601

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¿.

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.