What's being recalled
Companies: Biomet Uk Limited, Waterton Industrial Estate, Bridgend, United Kingdom, CF31 3XA.
How to identify it
Affected products: Avantage Cup Gripper Size 58; Lot or serial number: All lots.; Model or catalogue number: 110134058
Affected products: Avantage Cup Gripper Size 56; Lot or serial number: All lots.; Model or catalogue number: 110134056
Affected products: Avantage Cup Gripper Size 44; Lot or serial number: All lots.; Model or catalogue number: 110134044
Affected products: Avantage Cup Gripper Size 54; Lot or serial number: All lots.; Model or catalogue number: 110134054
Affected products: Avantage Cup Gripper Size 52; Lot or serial number: All lots.; Model or catalogue number: 110134052
Affected products: Avantage Cup Gripper Size 62; Lot or serial number: All lots.; Model or catalogue number: 110134062
Affected products: Avantage Cup Gripper Size 64; Lot or serial number: All lots.; Model or catalogue number: 110134064
Affected products: Avantage Cup Gripper Size 60; Lot or serial number: All lots.; Model or catalogue number: 110134060
Affected products: Avantage Cup Gripper Size 46; Lot or serial number: All lots.; Model or catalogue number: 110134046
Affected products: Avantage Cup Gripper Size 48; Lot or serial number: All lots.; Model or catalogue number: 110134048
Affected products: Avantage Cup Gripper Size 50; Lot or serial number: All lots.; Model or catalogue number: 110134050
The hazard
It was identified while using the Avantage inserter handles and grippers during the implantation of the acetabular shell, that the acetabular shell may not consistently disengage from the gripper when the trigger is unlocked. As a result, the inserter handle and gripper assembly may remain engaged with the implanted shell, preventing clean separation of the instrumentation from the implant after its seating.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)