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U.S. Department of Health and Human Services

Class 2 Device Recall Brand Name: Vector TAS 8mm Screw.

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 Class 2 Recall
Brand Name: Vector TAS 8mm Screw.
see related information
Date Posted September 12, 2013
Recall Status1 Terminated on September 11, 2014
Recall Number Z-2194-2013
Recall Event ID 66173
Product Classification Implant, Endosseous, Orthodontic - Product Code OAT
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.
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
Recalling Firm/
Manufacturer
Ormco/Sybronendo
1332 S Lone Hill Ave
Glendora, California 91740-5339
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
Action Ormco sent an "Urgent Medical Device Recall letter dated July 12, 2013, via USPS 1st class mail, along with a return form to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were informed of the recall, with product description, product codes, ship dates, contact information and instructions to return any affected product identified in stock, Additionally, doctors are instructed to proceed with treatment if the screw has already been placed and to take special care not to over-torque the screw upon removal. Periodic effectiveness checks will be conducted in order to follow up with non-responders. Please fax this acknowledgement form to the the following number to confirm receipt of this notification whether or not you have any affected products. (714) 288-4603.
Quantity in Commerce 4,786
Distribution Worldwide Distribution - USA (nationwide) including the countries of Canada, Australia, New Zealand, EU and ROW consignees.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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