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U.S. Department of Health and Human Services

Class 2 Device Recall ClassOne Orthodontics Buccal SS Tubes

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  Class 2 Device Recall ClassOne Orthodontics Buccal SS Tubes see related information
Date Initiated by Firm November 01, 2010
Date Posted February 15, 2011
Recall Status1 Terminated 3 on April 27, 2011
Recall Number Z-1246-2011
Recall Event ID 57587
Product Classification Orthodontic Tube - Product Code DZD
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.
Code Information 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)
Recalling Firm/
Manufacturer		 Ortho Organizers Inc
1822 Aston Ave
Carlsbad CA 92008-7306
For Additional Information Contact Rand Jadan
760-448-8600 Ext. 161
Manufacturer Reason
for Recall		 Products were mis-labeled as nickel free.
FDA Determined
Cause 2		 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).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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