| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01055-1 |
| Product Name/Description |
Sterile Percutaneous Reference Pin
Lot Numbers: 2023041134, 2023051138, 2022030438
Product Name: Sterile Percutaneous Reference Pin, 100mm, Sterile Percutaneous Reference Pin, 100mm, Sterile Percutaneous Reference Pin, 150mm
ARTG 123340
(Medtronic Australasia Pty Ltd - Unclassified) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has become aware that certain percutaneous pin lots have been identified as having a cross-pin that may render the percutaneous pin unable to fit into the tap cap, or too tight to remove the tap cap from the percutaneous pin once placed in the pelvis.
This issue is associated with recently manufactured lots of the Percutaneous Pin used during spinal surgeries.
If this issue occurs, the user may be unable to remove a tap cap from the percutaneous pin. This could result in surgical delay, additional intervention for removal and replacement of percutaneous pin, or modification of the surgical approach using an alternative device. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
1. Immediately locate and quarantine all unused impacted product(s).
2. Return the impacted product(s) to Medtronic following the instructions in the Customer Acknowledgement Form.
3. If the affected devices have already been used and/or discarded, customers should still complete and return the Customer Acknowledgement Form detailing that information.
4. This notice should be distributed to all staff who should be aware, or to any other organisation where the potentially affected devices have been transferred. |
| Contact Information |
0434 815 851 - Abel Anzaldo |