FDAFDA · Food and drugs·Recall number Z-2194-2013
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.
Published September 18, 2013 · Recall initiated: July 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ormco/Sybronendo
- Distributor
- Worldwide Distribution - USA (nationwide) including the countries of Canada, Australia, New Zealand, EU and ROW consignees.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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