| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01331-1 |
| Product Name/Description |
Beater-Positioner-Aligner
Product Code: 9057.20.555
Lot Numbers: 15AG0V0 and 16AG02J
ARTG Number: 176877
(Multipurpose Impactor Handle - Orthopaedic implant inserter/extractor) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
A Lima Orthopaedics investigation detected substandard welding performed by the supplier on the Beater-Positioner-Aligner. Specifically, the absence of base material pre-fusion and under-dimensioned welding radius was identified. There is a risk of injury to the surgeon or the patient, in case the flange of the instrument breaks and detaches with high speed from the body of the instrument. |
| Recall Action |
Recall |
| Recall Action Instructions |
Lima is advising users to quarantine affected stock from use. Lima Orthopaedics will replacing the affected stock in the consignment sets.
This action has been closed out on the 25/09/2018. |
| Contact Information |
03 9550 0221 - Lima Orthopaedics Customer Service |