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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00529-1
Product Name/Description G7 Positioning Guide Rod & G7 Positioning Guide Post

G7 Positioning Guide Rod
Part Number: 110003458
Lot Numbers: 360877, 377304, 424960, ZB130701, ZB130702, ZB130703, ZB130704, ZB130705, ZB131201, ZB140204

G7 Positioning Guide Post
Part Number: 110003500
Lot Numbers: 360877, 469610, 881430, ZB130701, ZB130702, ZB130703, ZB130901, ZB131001, ZB131002, ZB131101,
ZB140101

ARTG Number: 113463
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/05/2014
Responsible Entity Biomet Australia Pty Ltd
Reason/Issue Biomet has initiated this action following an investigation which identified that positioning guide rod may fracture during impaction of the acetabular shell. If the positioning guide rod fractures, then the positioning guide post may become stuck to the insertion handle.
Recall Action Recall
Recall Action Instructions Biomet is requesting their customers to immediately locate and remove the affected devices from circulation and arrange for the return of the device.
Contact Information 02 9878 6100 - Biomet Regulatory Affairs