| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00200-1 |
| Product Name/Description |
Medartis APTUS Wrist Plates
Part name: 2.5ADAPTIVE II TriLock DistRad.pl,pal re and 2.5 TriLock Dist.Rad.FPL.pl, palmar re
Part number: A-4750.106 and A-4750.124
Lot numbers: 23371373 and 23364417
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 |
15/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Medartis received a complaint about the plate being bent incorrectly. The radius plate was not bent according to specification “Left”. The bending machine was incorrectly set to bend a “Right” plate. This resulted in an incorrect shape.
Due to the incorrect shape of the radial plate, there is an increased risk of contact with the FPL (flexor policius longus) tendon if implanted, potentially causing and increased risk of tendon irritation or rupture. |
| Recall Action |
Recall |
| Recall Action Instructions |
Recall:
Inspect stock immediately and quarantine affect lots to prevent further use.
Customers are to return affected stock and replacement stock will be provided.
Implant Hazard Alert:
Medartis is advising surgeons that in addition to the recommendations according to the instructions for use, regular examination by ultrasound or similar (in particular of the flexor tendon) is recommended in addition to the usual radiological imaging. If tendon irritation is apparent, there is a risk of asymptomatic tendon rupture. The surgeon should assess if the affected implant should be removed and/or replaced with a compliant implant. |
| Contact Information |
1300 858 853 - Customer Service |