| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00235-1 |
| Product Name/Description |
Motec Wrist Arthrodesis System
Angled Double Taper 15° Short
Part number: 41-3101S
Angled Double Taper 15° Medium
Part number: 41-3102S
Angled Double Taper 15° Long
Part number: 41-3103S
Angled Double Taper 15° Extra long
Part number: 41-31014S
Lot numbers: All
ARTG 194619
(Medical & Optical Instruments Australia Pty Ltd - Prosthesis, internal, joint, wrist, radial/ulnar component) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
The design of the Angled Double Taper allows for rotation if the taper is not firmly secured in the Treaded implants.
When inserted correctly and firmly the Morse taper in the threaded implant will prohibit rotation.
There is a potential risk that the Angled Double Taper rotates around its own axis during healing if not inserted properly.
Failure to firmly engage the tapers of the Angled Double Taper into the Threaded Implants, or mobilising too early, can lead to unintentional rotation of the Angled Double Taper, resulting in fusion to occur in an undesirable wrist position.
Medical & Optical Instruments Australia Pty Ltd is updating the Instructions for Use (IFU) with new warnings for customers to acknowledge. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Surgeons are to maintain awareness of the updated IFU and inclusion of the following warning:
"Failure to firmly engage the tapers of the Angled Double Taper into the Threaded Implants, or mobilising too early, can lead to unintentional rotation of the Angled Double Taper and fusion to occur in an undesirable wrist position."
Surgeons are to be aware of:
- The design of the Angled Double Taper which allows for rotation if the taper is not firmly secured in the threaded implants. When inserted correctly and firmly secured the Morse taper in the threaded implant will prohibit rotation.
- Patients treated with the impacted product identified should continue to be followed per the normal protocol established by the patient’s surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol. Additional or more frequent patient monitoring or follow up may be required in accordance with clinical judgment.
This action has been closed out on 18/07/2024 |
| Contact Information |
justinw@medopt.com.au - Justin Wood |