| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00103-1 |
| Product Name/Description |
Knotless TensionTight Button Implant System
Part Number: AR-2350
Batch Number: 15109136
ARTG 385940
(Arthrex Australia Pty Ltd - Button Implant System - Orthopaedic fixation suture button) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
The device is assembled incorrectly. While it can be prepared but with difficulty and can be implanted, the suture will not slide through the button. This will be obvious to the user and require use of another properly loaded implant.
The surgeon may not be able to tighten the suture and cannot reduce the tendon onto the bone, requiring a new device.
The surgeon will have the opportunity to identify the issue when preparing the device and pulling the suture threader through the button, as the suture may be difficult to pull or adjust due to going against the teeth of the trap door.
It is likely the problem will be missed and the device will get implanted. Once implanted, the user will not be able to tighten the suture and reduce the tendon.
In both cases, the most likely outcome is a delay < 15 minutes to troubleshoot, possibly re-thread the suture threader wire loop properly to have the suture going in the correct direction or replace the device. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to quarantine and segregate any stock from batch 15109136.
Return the acknowledgement form to arrange a return.
Arthrex will provide Replenishment for affected stock, which is readily available.
Report any adverse health consequences experienced with the use of this product to Arthrex and TGA. |
| Contact Information |
1800 950 637 - Customer Service |