| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00311-1 |
| Product Name/Description |
Medartis APTUS TriLock Screw
Part name: 2.8 TriLock Screw 22mm, HD7, 1/Pkg
Part number: A-5850.22/1
Lot number: 24377397
GTIN: 76300378022PA
ARTG 206157
(Medartis Australia & New Zealand Pty Ltd - Orthopaedic fixation plate kit, non-biodegradable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
One lot of 16 mm screws was placed in packaging for 22 mm screws.
The outer packaging of the medical device indicates a different size to the one supplied in the box. The error in the packaging used does not affect the quality of the product within the packaging. |
| Recall Action |
Recall |
| Recall Action Instructions |
Inspect stock immediately and quarantine the incorrectly packaged stock on hand. Any sets with products from incorrect packaging are to be checked to ensure the correct length of the screws in the 22 mm slots; quarantine any 16 mm screws from the 22 mm screw slots.
Replacement of the products incorrectly packaged will be arranged as soon as possible after the products have been returned.
Recommendations for patients who have already received an incorrectly packaged implant: Post-operative routine examination is sufficient. No additional follow-up is needed.
This action has been finalised on 18/7/2024. |
| Contact Information |
1300 858 853 - Customer Service |