| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00304-1 |
| Product Name/Description |
Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling
(Supplied as part of the fixation system implantation kit)
Part Number: 314.560
Lot Number: 7722501
ARTG Number: 153950 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
Johnson & Johnson Medical have received a complaint that the location slot for the screw holding sleeve was machined 3 mm out of position. The presence of a screwdriver, (Part Number 314.560) which is not manufactured to specification, may result in a surgical delay due to the non-conformance. The combination of the non-conforming screwdriver and a retaining sleeve will result in a situation where the surgeon will have minor difficulty interfacing the screw with the driver and sleeve, but the surgeon should still be able to insert the screw. It is important to note that the surgeon may opt to utilise the screwdriver without the retaining sleeve. The resulting surgical delay is not anticipated to be clinically significant (<15 minutes) and no additional intervention is anticipated. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to quarantine and return the affected stock in their possession to JJM.
This action has been closed out on 12/09/2018. |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical |