FDA Medical Device Recalls (openFDA)
Sybron Dental Specialties: 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.
- Recall number
- Z-2195-2013
- Recalling firm
- Sybron Dental Specialties
- 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.
- Status
- Terminated
- Initiated
- 2013-06-06
- Posted
- 2013-09-12
- Terminated
- 2013-09-13
- Reason
- 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
- 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
- 1,091
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.
- Lot, serial or model codes
- 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"
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DYJ
- Firm FEI
- 2024312
- Firm city
- Orange
- Firm state
- CA
- 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