Reported Sep 18, 2013 · Terminated
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw…
Sybron Dental Specialties
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sybron Dental Specialties · 1717 W Collins Ave · Orange, CA · 92867-5422
Is this the product you have?
- AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices
- Product UsageAOA 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
- Lot codes and dates
- 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 belowProduct
- DescriptionHerbst 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
3000-00103000-00113000-00123000-00403000-00423000-00453000-00463000-00473000-00503000-00943000-0097
- Lot Number
"All Devices Manufactured from April 32013 to May 212013"
- Amount recalled
- 1,091
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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