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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00813-3
Product Name/Description E1-Tapered 10 degree +3mm Liner 32/39 (hip joint prosthesis, acetabular component)

Product Part Number: E1-103239
Lot Number: 2011010452
ARTG Number: 120149
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 9/08/2012
Responsible Entity Biomet Australia Pty Ltd
Reason/Issue Biomet Spain Orthopaedics S.L. has initiated this action following the investigation on a reported event. It has been confirmed that in a few cases the affected product does not properly fit in the acetabular cup.
Recall Action Hazard Alert
Recall Action Instructions Biomet Australia is contacting the treating/implanting surgeon regarding the issue so that the affected patient can be appropriately managed.
Contact Information 02 9878 6100 - Biomet Australia Regulatory Affairs