| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00290-1 |
| Product Name/Description |
Cross-Link Clamp for Rods, 6.0 mm
Model number: 498.813; 498.813S
Lot numbers: 2780518; 2781527; 2780516; 2780511; 2780509; 2780507
ARTG number: 133401 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
The pre-assembled Cross-Link Clamp is used with 6mm longitudinal rods and 3.5mm transverse rods to provide additional rotational stability to long posterior thoracolumbar constructs. Due to an error in production, the affected pre-assembled Cross-Link Clamp cannot be securely attached to 6mm longitudinal rods. If the clamp does not tighten appropriately there is potential for surgical delay. |
| Recall Action |
Recall |
| Recall Action Instructions |
Johnson & Johnson Medical is requesting end users to immediately identify and quarantine all unused products listed. Potentially affected product is to be returned to Johnson & Johnson Medical as soon as possible. This action has been closed-out on 4/08/2016. |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical |