| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00745-1 |
| Product Name/Description |
Dermatome AN
Item Number: 88710100
Lot Number: 700164
ARTG Number: 115929
(Zimmer Biomet - Dermatome, gas powered) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet has identified that specific serial numbers of Dermatome AN may have a loose control bar which could compromise the ability to control the thickness of the graft. The affected devices could also potentially have a loose width plate that if undetected, could result in an imperfect, yet still usable graft. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer Biomet is advising customers to immediately inspect stock and quarantine affected product. A Zimmer sales rep will contact sites to arrange return and replacement with an unaffected batch.
This action has been closed out on the 26/11/2018. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |