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U.S. Department of Health and Human Services

Class 2 Device Recall Spirit MB Bracket

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  Class 2 Device Recall Spirit MB Bracket see related information
Date Initiated by Firm March 25, 2014
Date Posted April 04, 2014
Recall Status1 Terminated 3 on April 18, 2014
Recall Number Z-1330-2014
Recall Event ID 67849
510(K)Number K943245  
Product Classification Bracket, plastic, orthodontic - Product Code DYW
Product Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013.

Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Code Information Part Number 494-0110, Lot Number 081351013.  
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 initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as distal/gingival, is misplaced. The misidentification may lead an orthodontist to place the bracket on the wrong tooth, leading to movement 10 degrees in the wrong direction.
FDA Determined
Cause 2
Use error
Action Ormco Corporation initiated this recall by sending recall letters to customers on March 25, 2014 via 1st class mail. The letter identified the affected product, problem and actions to be taken. The consignees are instructed to complete the "Return Form" and return any affected product in their inventory. The letter was written in Japanese language and accompanied by a "Return Form".
Quantity in Commerce 150 units
Distribution Internationally Distributed in the country of Japan.
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.
510(K) Database 510(K)s with Product Code = DYW and Original Applicant = SYBRON DENTAL SPECIALTIES, INC.
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