| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00257-1 |
| Product Name/Description |
Drill Sleeve 9.0/2.8, L 191 mm, f/AFN
(used with the Antegrade Femoral Nail System to hold and guide implants and instruments during orthopaedic surgery)
Part Number: 356.706
Multiple Lot Numbers affected
ARTG Number: 153950 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that the specified affected lots of the drill sleeve may not couple with the protection sleeve (part number 356.705) due to the potential for interference between these two devices. In the event that the drill sleeve would not couple with the protection sleeve, a surgical delay would likely occur as the situation is assessed and the next steps are determined. If a drill sleeve is not used, the accuracy of insertion of the guide wire and/or proximal locking screw could potentially be reduced and may potentially result in damage to surrounding structures or a mal-union/non-union requiring a re-operation.
The guide sleeve also provides mechanical support of the wire. Thus, if the sleeve is not used, the potential exists for guide wire breakage and an adverse tissue reaction if the entire guide wire is not removed despite the guide wire being implant grade. |
| Recall Action |
Recall |
| Recall Action Instructions |
Johnson & Johnson Medical (JJM) is advising users to quarantine all affected stock and return.
This action has been closed out on 7/09/2018. |
| Contact Information |
1300 562 711 - JJM Customer Service |