Recall MonitorHealth Products
Avantage Inserter Handles and Grippers
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Orthopaedics
Product: Avantage Inserter Handles and Grippers
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Avantage Cup Gripper Size 58 | All lots. | 110134058 |
| Avantage Cup Gripper Size 56 | All lots. | 110134056 |
| Avantage Cup Gripper Size 44 | All lots. | 110134044 |
| Avantage Cup Gripper Size 54 | All lots. | 110134054 |
| Avantage Cup Gripper Size 52 | All lots. | 110134052 |
| Avantage Cup Gripper Size 62 | All lots. | 110134062 |
| Avantage Cup Gripper Size 64 | All lots. | 110134064 |
| Avantage Cup Gripper Size 60 | All lots. | 110134060 |
| Avantage Cup Gripper Size 46 | All lots. | 110134046 |
| Avantage Cup Gripper Size 48 | All lots. | 110134048 |
| Avantage Cup Gripper Size 50 | All lots. | 110134050 |
Issue
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.