Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Herbst Universal Nut

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Herbst Universal Nut see related information
Date Initiated by Firm March 09, 2015
Date Posted April 22, 2015
Recall Status1 Terminated 3 on January 12, 2017
Recall Number Z-1505-2015
Recall Event ID 70787
Product Classification Clamp, wire, orthodontic - Product Code ECN
Product Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24
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 Product No. 90870, 90876 and 90879
Recalling Firm/
Manufacturer		 Specialty Appliance Works, Inc.
4905 Hammond Industrial Dr
Cumming GA 30041-3914
For Additional Information Contact Carolyn 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
Action Specialty 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 Commerce 14,428 Universal Nuts
Distribution Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
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.
-
-