Type of Product |
Medical Device |
TGA Recall Reference |
RC-2023-RN-00804-1 |
Product Name/Description |
Zimmer Dermatome Blades
Product code: 00-8800-000-10
Multiple lot numbers
ARTG 115927 (Zimmer Biomet Pty Ltd - Blade, dermatome, single use) |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
12/09/2023 |
Responsible Entity |
|
Reason/Issue |
There have been 38 complaints received related to skin grafts being thin and non-uniform when using specific lots of the blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area.
This recall does not affect any other batches/lots/versions of Zimmer Dermatome Blades or any other Zimmer Biomet products. |
Recall Action |
Recall |
Recall Action Instructions |
Customers should immediately quarantine affected devices and await further instructions from Zimmer regarding their removal.
This action has been finalised on 30/7/2024. |
Contact Information |
0434 660 820 - Mike Hand |