Ortho Organizers Inc: 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.

Recall number

Z-1246-2011

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.

Status

Terminated

Initiated

2010-11-01

Posted

2011-02-15

Terminated

2011-04-27

Reason

Products were mis-labeled as nickel free.

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

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).

Lot, serial or model codes

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)

510(k) numbers

not on file

PMA numbers

not on file

Product code

DZD

Firm FEI

2081322

Firm city

Carlsbad

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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