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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00268-1
Product Name/Description	Various Polyethylene Implants Multiple Item and Lot Numbers ARTG Numbers: 98451, 144584, 219196, 219825, 219841, 219858, 223027,223028, 225307, 226020, 227968, 246654, 249554 and 272677
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	24/02/2017
Responsible Entity	Zimmer Biomet Pty Ltd
Reason/Issue	Zimmer Biomet is conducting a lot specific medical device recall for various polyethylene implants. The affected products are being removed due to the potential presence of elevated endotoxin levels that exceed the specification limit. The issue was discovered during routine bacterial endotoxin testing (BET). To date, no complaints related to this issue have been received.
Recall Action	Recall
Recall Action Instructions	The relevant Zimmer Biomet sales representative will remove the affected product from each affected facility. There are no specific patient monitoring instructions that are recommended beyond the existing surgical follow-up protocol. This action has been closed-out on 19/03/2018.
Contact Information	02 9483 5426 - Zimmer Biomet Sales Associate