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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmNovember 18, 2004
Date PostedDecember 15, 2004
Recall Status1 Terminated 3 on June 17, 2005
Recall NumberZ-0309-05
Recall Event ID 30515
Product Classification Bracket, Metal, Orthodontic - Product Code EJF
ProductTitanium Orthos Bracket
Code Information Part Number: 448-6111 and lot numbers:04G21, 04G83, 04J29, 04H108, 04K77. Part Number:449-6111 and lot numbers: 04G15, 04J5, 04G14, 04H141, 04H77.
FEI Number 2016150
Recalling Firm/
Manufacturer		 Ormco Corporation
1332 S Lone Hill Ave
Glendora CA 91740-5339
For Additional Information ContactWendy Urtel
800-854-1741
Manufacturer Reason
for Recall		Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.
FDA Determined
Cause 2		Other
ActionRecall letters were mailed from 11/18 thru 11/23. Letters request return of product.
Quantity in Commerce6,257
DistributionNationwide and France, Luxembourg, Spain, Netherlands, Russia, Ireland, Italy, Germany, United Kingdom, Hungary, Finland, Denmark.
Total Product Life CycleTPLC 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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