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U.S. Department of Health and Human Services

Class 2 Device Recall AOA Mini RPE Screw Assembly

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 Class 2 Device Recall AOA Mini RPE Screw Assembly see related information
Date Posted September 12, 2013
Recall Status1 Terminated on September 13, 2013
Recall Number Z-2195-2013
Recall Event ID 66110
Product Classification Retainer, screw expansion, orthodontic - Product Code DYJ
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 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.
Code Information 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"










Recalling Firm/
Manufacturer
Sybron Dental Specialties
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7480
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action AOA sent a recall notification letter titled "Urgent-Medical Device Correction", on June 6, 2013 via USPS 1st class mail. The letter identified the affected product, reason for recall, images, and actions to be taken. Customers were instructed to complete and return the attached Acknowledgement Form to AOA. For questions contact the AOA Customer Support Department at 1-800-262-2551.
Quantity in Commerce 1,091
Distribution Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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