FDAFDA · Food and drugs·Recall number Z-2195-2013
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.
Published September 18, 2013 · Recall initiated: June 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sybron Dental Specialties
- Distributor
- Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.
- Lot
- 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"
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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