Z-1507-2015Class II

HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24...

Name: Z-1507-2015 HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24...
Creator: Specialty Appliance Works, Inc.
Published: 2015-03-09
License: https://open.fda.gov/license/

Specialty Appliances, LLC / initiated 2015-03-09 / Terminated

FDA source

Specialty Appliance Works, Inc. began a recall of HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst Appliance is used to affect changes in... on 2015-03-09. FDA classified it as Class II and gives the reason as "The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1507-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-09
Posted: 2015-04-22
Terminated: 2017-01-12
Recalling firm: Specialty Appliances, LLC
Product: HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism 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.
Product code: ECN Clamp, Wire, Orthodontic
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 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 in commerce: 14,428 Universal Nuts
Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Product codes and lots: Product No. 90900, 90904, 90907, and 90910

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1507-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1502-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-22
Z-1503-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-22
Z-1504-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-22
Z-1505-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-22
Z-1506-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-22
Z-1507-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-22
Z-1508-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-22
Z-1509-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-22
Z-1510-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-22
Z-1511-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-22

Product code ECN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)