FDA Medical Device Recalls (openFDA)
Specialty Appliance Works, Inc.: Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) 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.
- Recall number
- Z-1510-2015
- Recalling firm
- Specialty Appliance Works, Inc.
- Product
- Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) 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.
- Status
- Terminated
- Initiated
- 2015-03-09
- Posted
- 2015-04-22
- Terminated
- 2017-01-12
- Reason
- The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
- Root cause
- 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
- 14,428 Universal Nuts
- Distribution
- Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
- Lot, serial or model codes
- Product No. 91695 and 91696
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ECN
- Firm FEI
- 3004158247
- Firm city
- Cumming
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28