Device Recall AOA Mini RPE Screw Assembly

  • Model / Serial
    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"
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • Manufacturer Parent Company (2017)
  • Source
    USFDA