CLASS II Device recall · Reported 18 Sep 2013 · FDA Enforcement Report
AOA Mini RPE Screw Assembly , a component of Herbst recalled
Sybron Dental Specialties is recalling AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices, distributed nationwide in the US. The recall was initiated on 6 Jun 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2195-2013
- FDA event ID
- 66110
- Recalling firm
- Sybron Dental Specialties, Orange, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jun 2013
- FDA classified
- 12 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Dental Devices
Timeline
| 6 Jun 2013 | Recall initiated by company | |
| 12 Sep 2013 | Classified by FDA | +98 days |
| 18 Sep 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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"
Where was it sold?
Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sybron Dental Specialties
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|---|---|---|---|---|---|
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| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
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