| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01386-1 |
| Product Name/Description |
Doro Sterile Disposable Skull Pins
Product Code: PMI-3006-00
Lot Number: 17041
ARTG Number 112259 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Pro Med Instruments (PMI) has been made aware of two breakages of the Doro Sterile Disposable Skull Pins at the tip, which occurred during two surgical procedures. The breakages occurred at the very distal end of the conical part of the skull pin tip. These breakages did not cause any injury to the patient and PMI have not, to date, been made aware of any further adverse events.
In a worst case scenario, this issue could lead to slippage which may require remedial action, loosening of the positioning and a delay in surgical procedure or the tip remaining in the skull, which could lead to subsequent complications such as wound healing. |
| Recall Action |
Recall |
| Recall Action Instructions |
Life Healthcare is requesting customers:
1. Review the Sponsor supplied Customer letter and ensure all users of the device are informed of this recall. If you have transferred the affected items to third parties, forward a copy of the Customer Letter to them;
2. Check your stock for affected Doro Pins Ref: PMI-3006-00 Lot 1704;
3. If you have affected items quarantine them immediately and complete the relevant section in the supplied form;
4. Check any records where the affected lot numbers have been used prior to this notice for discrepancies in the skull pins. If the tips have been noted as not being intact ensure that any remaining pieces are removed from the patient; and
5. Please complete the supplied reply form and return by email to regulatory@lifehealthcare.com.au
This action has been closed out on the 22/10/2018. |
| Contact Information |
02 8114 1553 – Life Healthcare |