| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00087-1 |
| Product Name/Description |
Small Pedicle Probe ELL-IN 02 23-N
Model Reference Number: ELL-IN 02 23-N
Batch Number: 3-8213
ARTG Number: 228975 |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Spineart Australia has been made aware that there is a non conformance on the graduation of the device. The graduation is 30/40/45/60 mm instead of 30/40/50/60 mm. Investigation from the sponsor has determined that this engraving error comes from the etching step during manufacturing and had not been caught duing the manufacturers control step. No other batches of the same reference are affected by this issue.
There have been no reported events as a reuslt of this issue.
This action was undertaken prior to consultation with the Therapeutic Goods Adminsitration (TGA). |
| Recall Action |
Recall |
| Recall Action Instructions |
The affected item has been quarantined and returned to the manufacturer.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
03 9795 4591 - Spineart Australia |