| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00146-1 |
| Product Name/Description |
GemLock Long Hex Driver
Catalogue Number: TSVKIT
Lot Number on Label: 62702589*
Etched Lot Number of RHL2.5: 62699693
* Not all drivers used to assemble this kit lot are affected, as multiple lots of the driver were used to manufacture the kits. Drivers etched with lot 62632712, which function appropriately.
Lot Number on Label: 62743075
Etched Lot Number of RHL2.5: 62735177
ARTG number: 126570 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Dental identified that certain lots of the GemLock Long Hex Driver, Catalogue RHL2.5, may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant. The Affected Product was also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kit, Surgical, Complete, catalogue OPCST as well as the Tapered Screw-Vent Implant System Surgical Kit, Complete, catalogue TSVKIT. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer is requesting their customers to quarantine the affected units. A Zimmer distributor will arrange for the removal of affected products. This action has been closed-out on 4/08/2016. |
| Contact Information |
02 9483 5400 - Zimmer Pty Ltd |