| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00380-1 |
| Product Name/Description |
A-dec 311 Chair and A-dec 361 Support Centre
A-dec 311 Chair
ARTG Number: 118326
A-dec 361 Support Centre
ARTG Number: 118333
Multiple Serial Numbers (see attached) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
The strength of some screws (or "fasteners") may have been compromised due to a plating process issue. Under certain circumstances, the fasteners can become brittle, which might lead to a chair and/or delivery system instability. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is advising their customers that the dealer will be replacing the fasteners with screws unaffected by hydrogen embrittlement. |
| Contact Information |
02 8332 4000 - A-Dec Australia |