Consumers and health professionals are advised that Ormco, in consultation with the TGA, is recalling from the market one lot of its 8 mm Vector TAS Screw. Ormco has also issued a related hazard alert to orthodontists.
The 8 mm Vector TAS Screw is a dental implant screw used in the attachment of certain orthodontic appliances, such as braces. The screw is used temporarily and is removed after orthodontic treatment.
It has been identified that there is a potential for some screws from the affected lot to break during insertion or removal. If a screw breaks off at the gum level, it may require surgery to remove the remaining pieces.
The affected products are:
| Product | Part number | Lot number |
|---|---|---|
| 8 mm Vector TAS Screw | 601-0021 | 112911 |
| Vector TAS Starter Kit (10 Patient) | 601-0010 | 112911 (8 mm Vector TAS Screws are included in the kit) |
Information for consumers
Ormco has written to orthodontists who have been supplied with 8 mm Vector TAS Screws from the affected lot, providing further information regarding this issue and advice on how to treat affected patients.
Please note that the potential for breakage only relates to the process of inserting and removing the screws. There is no identified risk of the screws breaking once successfully inserted, prior to removal.
If you have had an orthodontic appliance fitted using dental implant screws and have any questions or concerns about this issue, contact your orthodontist.
Information for all health professionals
Patients who have had an orthodontic appliance fitted using dental implant screws and who have any questions or concerns about this issue should be referred to their orthodontist.
Information for orthodontists
Ormco has written to orthodontists who have been supplied with 8 mm Vector TAS Screws from the affected lot, providing further information regarding this issue, including details of the recall procedure and advice on how to treat affected patients.
Check any unused 8 mm Vector TAS Screws you have in stock. If any are from lot number 112911, do not use them and follow the recall procedure to return them to Ormco for replacement/credit.
If you believe an affected 8 mm Vector TAS Screw has already been used in treatment of a patient, proceed as normal. However, during removal, you are advised to take special care and consider advising the patient of the risk.
If you have any questions or concerns about this issue, contact Ormco Customer Care on 1800 643 603.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.