Recall Z-2194-2013— Ormco/Sybronendo

Class II FDA medical device recall by Ormco/Sybronendo, initiated 2013-07-12, terminated 2014-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after orthodontic treatment has been completed. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices.. Reason: Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. Use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces..

Recalling firm

Ormco/Sybronendo

Classification

Class II

Status

Terminated

Initiated

2013-07-12

Terminated

2014-09-11

Firm location

Glendora, CA, United States

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