Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01183-1
Product Name/Description Biomet 2.5MM offset tibial tray adaptor (tibial component of knee joint prosthesis)

Lot numbers: 439700 and 533400

ARTG Number: 98451
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 22/11/2012
Responsible Entity Biomet Australia Pty Ltd
Reason/Issue Specific batches were found to have an oversized adaptor locking insert that may not engage correctly with the insert tool screwdriver. This has the
potential to delay surgery. There are no problems expected post implantation.
Recall Action Hazard Alert
Recall Action Instructions Biomet is advising that once implanted, no additional risk to patient safety exists and no further action is required.
Contact Information 02 9878 6100 - Biomet Australia Regulatory Affairs