TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/p

FDA device recall Z-1509-2015 · posted 2015-04-22 · Terminated

Recall details

Recalling firm

Specialty Appliance Works, Inc.

Reason for recall

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

ECN

Quantity affected

14,428 Universal Nuts

Distribution

Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.

Date initiated

2015-03-09

Date posted

2015-04-22

Date terminated

2017-01-12

Location

Cumming, GA