Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a f

FDA device recall Z-2194-2013 · posted 2013-09-12 · Terminated

Recall details

Recalling firm

Ormco/Sybronendo

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.

Action taken

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

Root cause

Device Design

Status

Terminated

Product code

OAT

Quantity affected

4,786

Distribution

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

Date initiated

2013-07-12

Date posted

2013-09-12

Date terminated

2014-09-11

Location

Glendora, CA