| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00481-1 |
| Product Name/Description |
Zimmer Air Dermatome (Air powered surgical skin grafting device)
Part Number: 00-8801-001-00
Serial Numbers: 109445, 111058, 1111059, 111067, 111101, 111102, 111122
ARTG number: 115929 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer have received reports of broken planetary gear teeth, which can cause the Air Dermatome to either not operate or operate intermittently. This may cause a delay or postponement of the surgery or result in a suboptimal retrieval with potential of requiring an additional donor site. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are requested to remove the device from use and arrange with Zimmer Customer Service for a return and repair. |
| Contact Information |
02 9950 5400 - Zimmer Customer Service |