| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00741-3 |
| Product Name/Description |
44R82 Tube Clamp Adapter (Prosthetic component part)
ARTG Number: 129755 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
Otto Bock HealthCare GmbH has received a number of complaints that the adapters have shown signs of cracking during assembly or fitting. On two occasions cracks developed after the prosthesis was used for a short period of time. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Quarantine and return affected devices to Otto Bock Australia |
| Contact Information |
02 8818 2824 - Otto Bock Regulatory Affairs |