| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00952-1 |
| Product Name/Description |
oneFIT TOTAL KNEE PSI
Lot numbers: 230638, 230675, 230710, 230711, 230732, 230745, 230823, 230859, 230877, 231021, 231046
ARTG 259735
(Alphatec Australia Pty Ltd - Orthopaedic implantation application software) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
An above-specification level of endotoxins was found during a routine surveillance test for oneFIT Knee Guides.
It is therefore possible that oneFIT Knee Guides manufactured between 20 June and 28 September 2023 may present an endotoxin level above specification.
Endotoxins are a major component of the Gram-negative bacterial cell wall, which can be found on sterile products. Exposure to a high endotoxin burden in humans could result in symptoms including fever, low blood pressure, increased heart rate, or inflammatory response.
To date, no adverse event resulting from this issue has been reported to the manufacturer.
This action has been undertaken prior to notification to the TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Recall:
Customers should inspect stock and return affected lots.
Implant Hazard Alert:
In the event of an affected oneFIT Knee Guides has already been used, patients should be monitored for the described symptoms. No further action is necessary if the patient does not present complications or symptoms.
This action has been closed out on 28/02/2024 |
| Contact Information |
0499 228 924 - Mary Charlston |