The Recall Desk
HighFDA (Devices)·Z-2195-2013·Announced 2013-09-18

Sybron Recalls AOA Mini RPE Screw Assemblies Due to Incomplete Welds

Sybron Dental Specialties is recalling 1,091 AOA Mini RPE Screw Assemblies because they may have incomplete welds. These components are used in orthodontic devices like Herbst and MARA appliances.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect (incomplete weld) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Sybron Dental Specialties is recalling 1,091 units of the AOA Mini RPE Screw Assembly. The recall was initiated because the assembly may be missing a complete weld that joins one side of the arm with the screw body. This component is used in customized palate expander appliances and is a part of Herbst, MARA, and Fixed Metal devices.

The affected devices are removable functional appliances designed to modify jaw growth. They are generally attached to the patient's upper and lower molars or bicuspids using temporary stainless steel crowns or orthodontic bands. The recall covers devices manufactured between April 3, 2013, and May 21, 2013. The affected products were distributed nationwide in the United States as well as in Australia, Canada, and the European Union.

The recall includes specific part numbers ranging from 3000-0010 to 3000-0097. Affected product descriptions include the Herbst Bite Jumper, M.A.R.A., Rapid Palatal Expander, and various other orthodontic expanders and appliances. Consumers and healthcare providers should check their inventory for these specific part numbers and manufacturing dates.

The recalled product

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 gro
Manufacturer
Sybron Dental Specialties
Category
Medical Device — Orthodontic Appliances
Hazard
Affected units
1,091

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • 2013 to May 21
  • 2013"

Distribution

Distributed nationwide across the United States.

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