| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01147-1 |
| Product Name/Description |
VIPER 8, 9 & 10mm Large Diameter Polyaxial Screws, Lengths 70, 80 & 100 mm (To provide immobilisation and stabilisation of spinal segments in the treatment of instabilities or deformities of the thoracic, lumbar, and sacral spine)
Multiple Product Codes
All Lot Numbers
ARTG Numbers: 145290 & 178040 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
During insertion of VIPER large diameter long screws in high-torque circumstances (such as placement into the Ilium) the screw shank has the potential to separate from the polyaxial head. The disassembly of the screw requires that the shank be removed either via the drive feature in the shank or via alternate methods. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and return affected products to Johnson & Johnson Medical. |
| Contact Information |
1300 562 711 - Johnson & Johnson Medical Customer Service |