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U.S. Department of Health and Human Services

Class 2 Device Recall Titanium Orthos Brackets

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  Class 2 Device Recall Titanium Orthos Brackets see related information
Date Initiated by Firm March 25, 2014
Date Posted April 02, 2014
Recall Status1 Terminated 3 on October 27, 2014
Recall Number Z-1321-2014
Recall Event ID 67861
Product Classification Metal orthodontic bracket - Product Code EJF
Product Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Code Information Part Number 449-6212, Lot Number 121359169.  
Recalling Firm/
Manufacturer		 Ormco/Sybronendo
1332 S Lone Hill Ave
Glendora CA 91740-5339
For Additional Information Contact
909-962-5600
Manufacturer Reason
for Recall		 Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets.
FDA Determined
Cause 2		 Other
Action Recall notification letters sent to all affected consignees via 1st class mail on March 24, 2014. The consignees are instructed to complete the Return Form and have the option to return any affected product in their inventory to Ormco Corporation. The letter is dated "March 24, 2014" and titled: "URGENT: MEDICAL DEVICE RECALL". The letter informed customers of the recall, reason for recall, product description with part number and lot number, instructions to follow, and contact information. The letter was accompanied by a "Recall Return/Acknowledgement Form".
Quantity in Commerce 150 units
Distribution US and Canada.
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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