Home / Recalls / Ormco/Sybronendo / Z-2194-2013

Z-2194-2013 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

Recall Details

Product Type
Devices
Report Date
September 18, 2013
Initiation Date
July 12, 2013
Termination Date
September 11, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,786

Product Description

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 for Recall

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.

Distribution Pattern

Worldwide Distribution - USA (nationwide) including the countries of Canada, Australia, New Zealand, EU and ROW consignees.

Code Information

Lot Number 112911: 8 MM Vector TAS Screw, Part Number 601-0021 Lot Number 112911: Vector TAS Starter Kit (10 Patient), Part Number 601-0010

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