Z-0916-2008

Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584...

Name: Z-0916-2008 Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584...
Creator: Ormco Corporation
Published: 2007-10-31
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2007-10-31 / Terminated / root cause: manufacturing process

FDA source

Ormco Corporation began a recall of Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740 on 2007-10-31. The reason FDA records is "Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07". 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-0916-2008
Status: Terminated
Initiated: 2007-10-31
Posted: 2008-04-10
Terminated: 2012-03-22
Recalling firm: Ormco/Sybronendo
Product: Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740
Product code: DYH Adhesive, Bracket And Tooth Conditioner, Resin
Reason for recall: Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Ormco sent fourteen (14) consignees Urgent Device Recall Notification via U.S. First Class mail on October 31, 2007. There were two (2) additional letters sent to the consignees in France that were translated into French. The consignees were instructed to complete the Return Form and return any affected product in their inventory. Periodic effectiveness checks will be conducted in order to follow up with non-responders. For more information, contact firm at 1-800-854-1741.
Quantity in commerce: 4 kits (Total US and Internationally)
Distribution: Worldwide Distribution-USA states of IL, NY, LA, CA, NJ, NV and SC and countries of Canada, France and South Africa.
Product codes and lots: Part Number 740-0322, Lot Number 2792584

Product code DYH

K061481Class IIGrenglooOrmco Corp. / cleared 2006-07-06

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)