Z-2194-2013 Class II Terminated
FDA device recall Z-2194-2013 was initiated by Ormco/Sybronendo on July 12, 2013 and is designated Class II. 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… The recall status is terminated (terminated September 11, 2014). Affected quantity: 4,786.
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