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Terminated

Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740

FDA Recall Z-0916-2008 · Posted 2008-04-10

Recalling FirmOrmco Corporation
Recall StatusTerminated
Product CodeDYH
Date Initiated2007-10-31
Date Terminated2012-03-22
Product Quantity4 kits (Total US and Internationally)

Reason for Recall

Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.

Firm 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.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution-USA states of IL, NY, LA, CA, NJ, NV and SC and countries of Canada, France and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061481GRENGLOOOrmco Corp. · 2006-07-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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