| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2019-RN-00762-1 |
| Product Name/Description |
twinSys impactor with offset
Item Number: 51.34.0446
Batch Numbers: 6054487, 6061532, 6063726, 6065504, 6066616, 6067637, 6068893, 6070147
ARTG: 184413
(Mathys Orthopaedics Pty Ltd - Surgical procedure kit, orthopaedic, reusable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/05/2019 |
| Responsible Entity |
|
| Reason/Issue |
Mathys AG Bettlach's (manufacturer) global post-market surveillance data indicated that during impaction of the hip stem there is an increased rate of breakage of the tip of the ‘twinSys impactor with offset’ of the listed batches. In certain cases, the tip could not be removed from the impact hole of the shaft and remained in situ. Examination of the material found that it was not sufficiently suitable for such an impact-stress instrument.
If the tip of the instrument remains in the impact hole, this does not alter the mechanical nor the chemical properties of the implant. However, no part of the instrument is supposed to remain in the patient's body. This can lead to slow corrosion of the metal piece.
In the event of revision surgery, the extractor cannot be positioned as intended, which can hamper removal of the implant.
This action has been undertaken prior to notification to the TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Mathys Orthopaedics has contacted impacted facilities and arranged return of kits containing impacted instruments.
This action has been closed out on 24/03/2021 |
| Contact Information |
02 9417 9200 - Mathys Orthopaedics |