Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00142-1
Product Name/Description DVR ePAKs

All lots are affected
Multiple Part Numbers affected

ARTG Number: 210295
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/02/2016
Responsible Entity Biomet Australia Pty Ltd
Reason/Issue Iron oxidation has been found on components (mainly drill bits) contained in the DVR ePAKs.
A delay in surgery, less than 30 minutes may occur if surgical staff proceeds to re-sterilise the product or locate alternative products.

If oxidative material would flake off a component contained within the ePAK and enter the surgical field/wound, an inflammatory reaction may occur. The inflammatory reaction may result in a foreign body reaction and/or metal hypersensitivity.
Recall Action Recall
Recall Action Instructions Zimmer Biomet is advising users to quarantine affected stock for return to Zimmer.
Contact Information 02 9483 5426 - Zimmer Biomet