| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00094-1 |
| Product Name/Description |
balanSys Knee System (CR, UC, PS and RP)
balanSys Bone Orientated 4in1 SMaRT Instruments
Article No: 336.030.053
balanSys BICON Knee System Template
Article # 330.030.034
balanSys PS Knee System Template
Article # 330.030.035
balanSys PE Trial Inlay 67/8-20.5
Article # 71.34.0222 - 71.34.0227
balanSys PE Trial Inlay 67/8-23
Article # 71.34.0263 - 71.34.0269
balanSys CR/PS Tibial Template 67
Article # 71.34.0538
balanSys RP Trial Tibial Plateau 67
Article # 71.34.0296 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
The incorrect size determination table in Surgical Technique indicates that the femoral component size C is compatible with a tibial inlay/tibial plateau size 67. However, tibial components size 67 may be correctly used only with the smaller femoral components sizes A or B.
The incompatible combination of the balanSys CR, UC and PS systems (fixed bearing)may result in the following risks:
- There is an immediate risk that the knee cannot be optimally equilibrated, which may lead to pain and instability.
- In the long term, there is a risk of increased wear of the polyethylene, which may lead to pain, osteolysis, tibial loosening, instability and revision surgery.
In the balanSys RP system (rotating platform), there is a risk of increased soft-tissue irritation associated with pain. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Mathys Orthopaedics is advising surgeons and hospitals that the Surgical Technique is incorrect as it indicates that the femoral conmponent size C is compatible with a tibial inlay/tibial plateau size 67. Tibial components size 67 should only be used with smaller femoral components size A and B.
A single patient was implanted with the incorrect combination in Australia. The associated surgeon has been contacted and provided with additional information for the ongoing management of the patient. |
| Contact Information |
02 9840 8212 - Mathys Orthopaedics Pty Ltd |