| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01016-1 |
| Product Name/Description |
Low Profile Primary Guide
Part Number: RBL2320
Lot Number: 538351, 538352, 544036, 554505, L1810012, L1902009, L1909017, L2001005, L2005002, L2010046, L2010048
ARTG 306126
(Medical & Optical Instruments Australia Pty Ltd - Fixation system implantation kit Internal - Fixation system implantation kit, internal) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for breakage during use of Part Number RBL2320, Low Profile Primary Guides used in the Ribloc U Plus Chest Wall Plating system. This system is intended to stabilise and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstruction of the chest wall and sternum. If device breakage occurs during surgery, and a fragment of the device remains undetected post-operatively, significant unplanned medical intervention may be required. An unretrieved fragment has the potential to cause infection, result in a histological response, or migrate within the body. |
| Recall Action |
Recall |
| Recall Action Instructions |
All product identified and to be removed from the market.
This action has been closed out on 5/3/2024. |
| Contact Information |
ellie.wood@acumed.net - Ellie Wood |