Z-1084-2013Class II

Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0

Name: Z-1084-2013 Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0
Creator: Ormco/Sybronendo
Published: 2013-03-08
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2013-03-08 / Terminated / root cause: packaging

FDA source

Ormco/Sybronendo began a recall of Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during... on 2013-03-08. FDA classified it as Class II and gives the reason as "Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correctly identifies the product as gingival...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1084-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-08
Posted: 2013-04-10
Terminated: 2013-09-04
Recalling firm: Ormco/Sybronendo
Product: Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
Product code: DZD Tube, Orthodontic
Reason for recall: Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correctly identifies the product as gingival (0) offset brackets, but actually contains distal (10) offset brackets. Use of the affected product may cause unintended rotation of the molars. Although reversible, a delay in
Root cause tag: packaging
FDA root cause: Packaging
Action: Ormco sent an Urgent Medical Device Recall letter dated March 8, 2013 to all affected customers, via USPS 1st class mail. The letter identified the affected product, problem and actions to be taken. The consignees were instructed to complete the Return Form and return any affected product identified in stock. For questions contact Ormco Customer Care.
Quantity in commerce: 8210
Distribution: Worldwide Distribution - USA (nationwide) including the country of EU.
Product codes and lots: Part Number 438-0184 Lot Number 051063597

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1084-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1084-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-10

Product code DZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)