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Terminated

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.

FDA Recall Z-2195-2013 · Posted 2013-09-12

Recalling FirmSybron Dental Specialties
Recall StatusTerminated
Product CodeDYJ
Date Initiated2013-06-06
Date Terminated2013-09-13
Product Quantity1,091

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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