Z-0201-2012

Spirit MB Brackets, part #494-1211. The brand name of the device is Spirit MB Brackets, an orthodontic...

Name: Z-0201-2012 Spirit MB Brackets, part #494-1211. The brand name of the device is Spirit MB Brackets, an orthodontic...
Creator: Ormco Corporation
Published: 2011-05-18
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2011-05-18 / Terminated / root cause: design

FDA source

Ormco Corporation began a recall of Spirit MB Brackets, part #494-1211. The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the... on 2011-05-18. The reason FDA records is "Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0201-2012
Status: Terminated
Initiated: 2011-05-18
Posted: 2011-11-16
Terminated: 2012-04-24
Recalling firm: Ormco/Sybronendo
Product: Spirit MB Brackets, part #494-1211. The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Product code: DYW Bracket, Plastic, Orthodontic
Reason for recall: Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
Root cause tag: design
FDA root cause: Device Design
Action: Ormco Corporation sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product. If any of the affected product is found, customers are directed to contact Ormco Customer Care at 1-800-854-1741 to receive a RMA number. The RMA number will allow a quick return and replacement or credit. Additionally, a Recall Return/ Acknowledgement Form was attached for customers to complete and return via fax to 909-962-5605.
Quantity in commerce: 135 packs
Distribution: Worldwide Distribution-USA (nationwide) including the states of FL, MN, TX, and VA, and the countries of Australia, France, Germany, Italy, Japan, Mexico, Morocco, Netherlands, New Zealand, South Africa, Turkey, and Ukraine.
Product codes and lots: Lot #111069607, 031144457

Product code DYW

K943245Class IISpirit MbSybron Dental Specialties, Inc. / cleared 1994-08-23

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)