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U.S. Department of Health and Human Services

Class 2 Device Recall Herbst Universal Nut

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 Class 2 Device Recall Herbst Universal Nutsee related information
Date Initiated by FirmMarch 09, 2015
Date PostedApril 22, 2015
Recall Status1 Terminated 3 on January 12, 2017
Recall NumberZ-1502-2015
Recall Event ID 70787
Product Classification Clamp, wire, orthodontic - Product Code ECN
ProductHerbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
Code Information 1405016
Recalling Firm/
Manufacturer		 Specialty Appliance Works, Inc.
4905 Hammond Industrial Dr
Cumming GA 30041-3914
For Additional Information ContactCarolyn Thomas
678-513-4408 Ext. 226
Manufacturer Reason
for Recall		The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
FDA Determined
Cause 2		Under Investigation by firm
ActionSpecialty Applicances sent an Urgent Voluntary Productionn Field Correction Notification dated March 9, 2015, to all affected customers who received the Herbst Appliances and for sales supply orders. The letter advised doctors to monitor the appliance during routine follow-up appointments for signs of corrosion, and for sales supply orders to return affected components to the lab for replacement. Customers were asked to complete and return the enclosed Field Correctivve Action Response Form and return via fax to 678-513-7345. To return affected devices call 800-522-4636 to receive instruction as to how to return it to Speciality Applicances. In the event that customers observe signs of corrosion or a fracture, they should contact customer service at 800-522-4636 or their sales representative. For questions customers should call 800-522-4636 For questions regarding this recall call 678-513-4408, ext 226.
Quantity in Commerce14,428 Universal Nuts
DistributionWorldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
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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