| TGA Action ID |
RC-2025-RN-01008-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Zimmer Air Dermatome and Zimmer Dermatome AN
Item Numbers: 00-8801-001-00 & 88710100
Multiple item lot numbers and serial numbers |
| ARTG Number |
115929 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Worldwide, multiple complaints have been received related to Air Dermatome devices that were cutting beyond the proper depth. Inspections of the returned complaint devices confirmed that affected devices may have a misaligned thickness control bar. If the device has a misaligned thickness control bar from manufacture, it would be expected to manifest such that any potential negative outcomes would be present upon the first few uses. |
| Instructions for Customers/Users |
For customers with affected stock, Device Technologies will be in contact to coordinate return and repair in a phased approach. Due to the likelihood that the issue would occur upon the first few uses, affected devices that have not exhibited the issue may continue to be used until requested from Device Technologies to return for repair or preventative maintenance. |
| Action Commencement Date |
8/12/2025 |
| Responsible Entity |
|
| Contact Information |
0410 653 862 - Brendan Leslie (Sales Manager) |