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

FDA Device Recall #Z-2194-2013 — Class II — July 12, 2013

Recall Summary

Recall Number Z-2194-2013
Classification Class II — Moderate risk
Date Initiated July 12, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ormco/Sybronendo
Location Glendora, CA
Product Type Devices
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.

Lot / 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

Other Recalls from Ormco/Sybronendo

Recall # Classification Product Date
Z-1257-2020 Class II SnapLink, Ref Part No. 438-2190, L6R SnapLink, ... Jan 17, 2020
Z-1258-2020 Class II SnapLink, Ref Part No. 438-2191, L6L SnapLink, ... Jan 17, 2020
Z-2286-2020 Class II Ormco Damon Q2 Orthodontic Metal Bracket, Part ... Jan 14, 2020
Z-0413-2018 Class II Elements Obturation Unit (EOU) used with respec... Dec 27, 2017
Z-2836-2016 Class II Sealapex Xpress, Part No. 33639 The brand na... Aug 31, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.