Z-1246-2011

ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO...

Name: Z-1246-2011 ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO...
Creator: Ortho Organizers Inc
Published: 2010-11-01
License: https://open.fda.gov/license/

Ortho Organizers Inc / initiated 2010-11-01 / Terminated / root cause: labeling and UDI

FDA source

Ortho Organizers Inc began a recall of ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each); ClassOne Orthodontics Buccal SS Tubes... on 2010-11-01. The reason FDA records is "Products were mis-labeled as nickel free". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1246-2011
Status: Terminated
Initiated: 2010-11-01
Posted: 2011-02-15
Terminated: 2011-04-27
Recalling firm: Ortho Organizers Inc
Product: ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each); ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-328, NF DB UL 6 Convertible .018-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-418, NF DB UL/LR 6&7 Mini Single .022 0T 0O; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-427, NF DB UR 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Label ID Reference Number 351-428, NF DB UL 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-459, NF DB LR 6 Convertible .022-25T 4DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-460, NF DB LL 6 Convertible .022-25T 4DO HK-Each.
Product code: DZD Tube, Orthodontic
Reason for recall: Products were mis-labeled as nickel free.
Root cause tag: labeling and UDI
FDA root cause: Pending
Action: An Urgent: Product Recall Notice letter, dated November 1, 2010 was sent to consignees at the distribution level who received recalled products. Consignees were instructed to do the following: 1) Carry out a physical count of current inventory and record this data on the business reply card provided with this notice. Return the enclosed Reply Card with the amount remaining inventory to Ortho Organizers, Inc., Carlsbad, CA 92008 within 10 days of receipt of this notification. 2) Immediately cease distribution/use of this product and remove from your shelves. 3) Notify all of your retail customers with the Urgent: Product Recall Notice (Retail Level) letter who purchased the affected item numbers from you that the affected items are stainless steel and contain nickel. 4) Contact your sales representative to return any unused items. Return any unused product within 30 days. Please clearly mark the return carton Recall Material Enclosed. Ortho Organizers shall accept any product covered by this recall and credit your account for all product and shipping costs.
Quantity in commerce: 1300
Distribution: Worldwide Distribution -- USA, including states of CA, CO, IL, LA, MI, MN, PA & TX and countries of CA (Canada), BE (Belgium), NO (Norway), and CO (Columbia).
Product codes and lots: Buccal SS Tubes Item Numbers: #351-327 (all lots) #351-328 (all lots) #351-418 (all lots) #351-427 (all lots) #351-428 (all lots) #351-459 (all lots) #351-460 (all lots)

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)