Z-0204-06

Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211 Lot Number 100514071 and 100512012

Name: Z-0204-06 Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211 Lot Number 100514071 and 100512012
Creator: Ormco Corporation
Published: 2005-11-03
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2005-11-03 / Terminated

FDA source

Ormco Corporation began a recall of Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211 Lot Number 100514071 and 100512012 on 2005-11-03. The reason FDA records is "Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0204-06
Status: Terminated
Initiated: 2005-11-03
Posted: 2005-11-26
Terminated: 2006-01-11
Recalling firm: Ormco/Sybronendo
Product: Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211 Lot Number 100514071 and 100512012
Product code: DYW Bracket, Plastic, Orthodontic
Reason for recall: Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
FDA root cause: Other
Action: Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.
Quantity in commerce: 1420
Distribution: Nationwide
Product codes and lots: Lot Number 100514071 and 100512012

Product code DYW

K052477Class IIDamon 3 ModifiedOrmco Corp. / cleared 2005-11-30

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)