| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01320-1 |
| Product Name/Description |
RHD2.5 Hex Driver, 2.5mm with GemLock Retention, contained within TSVKIT Surgical Kit
Surgical Kit
Item Number: TSVKIT
Lot Number: 63666560
UDI Number: (01)00889024019614(10)63666560
ARTG Number: 126570 (Biomet 3i Australia Pty Ltd - Dental implant suprastructure device, temporary) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet has identified that the 2.5mm GemLock Hex Driver, RHD2.5 contained within a Surgical Kit may contain a manufacturing anomaly affecting the geometry of the driver’s hex feature, which prevents it from properly engaging with mating components.
The RHD2.5 Hex Driver is used to carry and drive the implant into the osteotomy by connecting to the Fixture Mount/Transfer or directly to the implant. Two instruments, RH2.5 and RH2.5L, may be utilised as alternatives to the RHD2.5. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer Biomet is advising customers to review their inventory and return affected drivers. Please note that this recall is specific to the hex driver and as such there is no need to return entire surgical kit. Zimmer Biomet will provide replacement RHD2.5 hex drivers to affected customers upon return of affected RHD2.5 hex drivers. Two instruments, RH2.5 and RHL2.5 may be utilised as alternatives to the RHD2.5.
This action has been closed out on 25/10/2018 |
| Contact Information |
1800 802 457 - Zimmer Biomet |