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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 Zimmer Biomet Pty Ltd
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