FDA Device recall Z-2194-2013
Brand Name: Vector TAS 8mm Screw
- FDA Device
- Class II
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class II recall of Brand Name: Vector TAS 8mm Screw by Ormco Sybronendo, citing 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 cau….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2194-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-12 |
| Published | 2013-09-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ormco Sybronendo |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2194-2013%22
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