| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00977-1 |
| Product Name/Description |
Pangea, USS II Polyaxial, Matrix Deformity, Matrix Degenerative and Pangea Degenerative Systems, Pedicle Awl 4.0mm with Canevasit and Silicone Handle (internal fixation system)
Multiple Technique Guides Affected
Labelling:
Pedicle Awl 4.0mm with Canevasit Handle
Product Code: 388.550
Pedicle Awl 4.0mm with Silicone Handle
Product Code: 388.656
ARTG Number: 155807 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
The Surgical Technique Guides and product labelling for the affected systems currently describe the Pedicle Awls as 4.0mm for use with screws (4.0mm – 7.0mm). These awls should be used with 5.0mm – 7.0mm screws. In the event that a Ø4mm Awl is used for a Ø4mm screw, there is a risk that perforation of the cortex will be too wide and may result in screw pull-out or loosening. In the event that the cortex is perforated wider than needed for insertion of a Ø4mm screw, the failure would not typically be recognised. Cases may occur, however, where a surgeon’s perception of torque to insert the screw does not have the desired level of fixation. In this case, the issue may be recognised. There have not been any reports of patient injuries as a result of the current labelling, and there have been no changes to the design or manufacture of the Pedicle Awls. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Johnson & Johnson Medical are providing a web link for users to obtain copies of the revised technique guides and labelling. This action has been closed-out on 29/08/2016. |
| Contact Information |
1800 252 194 - JJM |