AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Ass

FDA device recall Z-2195-2013 · posted 2013-09-12 · Terminated

Recall details

Recalling firm

Sybron Dental Specialties

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.

Action taken

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

Status

Terminated

Product code

DYJ

Quantity affected

1,091

Distribution

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

Date initiated

2013-06-06

Date posted

2013-09-12

Date terminated

2013-09-13

Location

Orange, CA