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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00722-3
Product Name/Description Low Profile Abutment Hexed Castable Cylinder, Model LPCCC1

Lot no's:2010100001, 2010080684, 2010090191
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 30/08/2012
Responsible Entity Biomet 3i Australia Pty Ltd
Reason/Issue Biomet 3i has become aware that some packages labelled LPCCC1, Hexed Castable Cylinder, may contain LPCCC2 Non-Hexed Castable Cylinder. According to Biomet 3i, this condition will not have any effect on patient health. However, difficulty may be encountered in the lab durung use due to the ease of rotation of the non hexed cylinder.

This recall action was not notified to the TGA before it was initiated by Biomet 3i Australia Pty Ltd.
Recall Action Recall for Product Correction
Recall Action Instructions The sponsor is asking users to return affected stock for a replacement.
Contact Information 02 9855 4444 - Biomet 3i