Recall Z-2195-2013— Sybron Dental Specialties

Class II FDA medical device recall by Sybron Dental Specialties, initiated 2013-06-06, terminated 2013-09-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Sybron Dental Specialties

Classification

Class II

Status

Terminated

Initiated

2013-06-06

Terminated

2013-09-13

Firm location

Orange, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.