| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00962-1 |
| Product Name/Description |
balanSys RP Tibial Plateau TiNbN cem
Item Numbers: 72.34.0155, 72.34.0156, 72.34.0157, 72.34.0158, 72.34.0159, 72.34.0160, 72.34.0161, 72.34.0162
Reference Number: FSCA 17/03
ARTG Number: 211086 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Mathys has received several reports about soft tissue reactions due to the wear of particles of unknown origin detected during a revision of surgereies of balanSys RP TiNBN total knee protheses in patients that are suffering persisting pain and synovitis.
This debris can cause infections leading to soft tissue damage which may compromise the result of the total knee arthroplasty.
Patients who experience symptoms including limited mobility, pain, swelling, etc. may need to contact their treating physician. The need for any additional follow-up, MRI or ultrasound scans, arthroscopy or revision surgery should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances. |
| Recall Action |
Recall |
| Recall Action Instructions |
This action has been closed-out on 09/08/2017. |
| Contact Information |
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