Z-2195-2013Class II

AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices

Name: Z-2195-2013 AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices
Creator: Sybron Dental Specialties
Published: 2013-06-06
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2013-06-06 / Terminated / root cause: design

FDA source

Sybron Dental Specialties began a recall of AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA... on 2013-06-06. FDA classified it as Class II and gives the reason as "The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2195-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-06
Posted: 2013-09-12
Terminated: 2013-09-13
Recalling firm: Sybron Dental Specialties, Inc.
Product: AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.
Product code: DYJ Retainer, Screw Expansion, Orthodontic
Reason for recall: The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.
Root cause tag: design
FDA root cause: Device Design
Action: AOA sent a recall notification letter titled "Urgent-Medical Device Correction", on June 6, 2013 via USPS 1st class mail. The letter identified the affected product, reason for recall, images, and actions to be taken. Customers were instructed to complete and return the attached Acknowledgement Form to AOA. For questions contact the AOA Customer Support Department at 1-800-262-2551.
Quantity in commerce: 1,091
Distribution: Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.
Product codes and lots: The AOA Mini RPE Screw Assembly is a component used in customized palate expander appliances assembled by prescription. The affected assembly may be found in products listed in the table below: Product Description: Herbst Bite Jumper Herbst Appliance Acrylic Splint M.A.R.A. (Mandibular Anterior Reposi tioning Appliance) Rapid Palatal Expander Lower Expander DeLuke Bonded Frameless Expander Haas Expander AOA Mini Rapid Palatal Expander Dischinger Lower Expansion Appliance Tracy/Hilgers MDA Appliance Distal Jet Molar Uprighter Part Number: 3000-0010 3000-0011 3000-0012 3000-0040 3000-0042 3000-0045 3000-0046 3000-0047 3000-0050 3000-0094 3000-0097 Lot Number: "All Devices Manufactured from April 3, 2013 to May 21, 2013"

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2195-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2195-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-12

Product code DYJ

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)