| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00746-1 |
| Product Name/Description |
Pro-Fix Precision Fixation System – Contra Angle Driver Blade
Product Code: PFDBCA
Lot Number: AD12004A
ARTG 405391
(Pacific Dental Specialties Pty Ltd - Pro-Fix Precision Fixation system - Craniofacial bone screw, non-biodegradable) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
27/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
Lot AD12004A of product code PFDBCA has blades that are slightly outside of the specified diameter, preventing them from fitting into the intended handpiece.
The non-conforming condition does not represent a hazard to patient safety and no special patient remediation measures or other actions need to be taken. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should inspect stock and quarantine any units on hand from the affected lot numbers. For further information on returning affected product please email purchasing@pacificspecialties.com.au.
After receipt of a completed Customer Response Form, a credit will be applied to the relevant invoice. |
| Contact Information |
1800 725 245 - Pacific Dental Specialties |