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.
This recall has been terminated (originally issued February 15, 2011).
- Company
- Ortho Organizers, Inc.
- Recall Initiated
- November 1, 2010
- Posted
- February 15, 2011
- Terminated
- April 27, 2011
- Recall Number
- Z-1246-2011
- Quantity
- 1300
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Products were mis-labeled as nickel free.
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 / Code Info
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)
Root Cause
Pending
Action Taken
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.