Z-2194-2013Class II

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

Name: Z-2194-2013 Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to...
Creator: Ormco/Sybronendo
Published: 2013-07-12
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2013-07-12 / Terminated / root cause: design

FDA source

Ormco/Sybronendo began a recall of 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... on 2013-07-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2194-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-12
Posted: 2013-09-12
Terminated: 2014-09-11
Recalling firm: Ormco/Sybronendo
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.
Product code: OAT Implant, Endosseous, Orthodontic
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2194-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2194-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-12

Product code OAT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)