| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00569-1 |
| Product Name/Description |
Pull Reduction Device for Percustaneous Drill Guide 4.3mm (Supplied as part of the VA Distal Femur set)
Part Number: 03.120.023
Multiple lot numbers affected
ARTG Number: 153950 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
The affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which
could result in intraoperative breakage.In the event of an intraoperative breakage a surgical delay could occur. Breakage of the instrument into fragments during active use could lead to a significant prolongation of surgery time as the surgeon attempts to retrieve the pieces including use radiographic imaging to determine location and size of fragment. |
| Recall Action |
Recall |
| Recall Action Instructions |
Johnson & Johnson Medical is requesting their customers to check their inventory to determine if they have any affected product. Affected stock must be quarantined in preparation for return to Johnson & Johnson Medical. This action has been closed-out on 05/12/2016. |
| Contact Information |
1300 562 711 - Customer Service |