| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00964-1 |
| Product Name/Description |
Adapter for Colibri, Electric Pen Drive and Light Adapter for Colibri and Colibri II hand piece
Adapter for Colibri, Electric Pen Drive
Product Number: 05.001.024
Light Adapter for Colibri and Colibri II hand piece
Product Number: 05.001.108
All Lot Numbers
ARTG Number: 157072 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
The Adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) System to operate the Colibri and Colibri II with the EPD consoles. The adaptor can be inserted into the Colibri or Colibri II handpiece and removed like a battery pack.
There is a potential for the Adapter for Colibri and Adapter for Colibri II to generate excessive internal pressure that may cause the respective products to burst. Preliminary tests for this failure mode by the manufacturer have determined this scenario is highly unlikely to occur. There have been no injuries as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
JJM is advising users to inspect stock and quarantine any units of the affected adapters. The Colibri Drill system is able to be operated by the use of specific batteries; listed below. These products will be made available.
• Universal battery charger, Product 05.001.204
• Battery case, Product 532.132
• 14.4V Lithium-Ion battery Product 532.103
• Sterile transfer product 532.104
This action has been closed out on 06/08/2019 |
| Contact Information |
1300 562 711 - JJM Customer Service |