| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01423-1 |
| Product Name/Description |
Spectra System/Legacy Guided Surgery Handle Kit Inserts
Part Numbers: G-HK
Kit Lot Numbers: 42562, 52987, 64245 and 74772
ARTG Number: 296286 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Implant Direct Oceania Pty Ltd is informing users of a recall of four (4) lots of Spectra System/Legacy Guided Surgery Handle Kit/Inserts due to receiving 3 complaints on these products. Through the reporting process, Implant Direct have found that the G-HK Guided Surgery Handle inserts may be out of Implant Direct specification. The 3.4mm guide insert will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide may be too large for the drill. These discrepancies may lead to the possibility of a delay in procedure for the patient if the drilling sequence is discontinued or the clinician would need to continue the surgical procedure without the use of the drill guide.
There have been no injuries as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Implant Direct is advising users to inspect stock and return affected units.
This action has been closed out on 24/03/2020 |
| Contact Information |
1800 654 953 - Implant Direct Oceania Australia Customer Care |