| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00680-1 |
| Product Name/Description |
Ankle Arthrodesis Nail 611AFN
Drill Bit Model Number: MJU777
Lot Numbers 11D463 and 12E794
ARTG Number: 112287 |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Despite being guided by drill reference MJU775, cases of drill breakage during surgery have been received by Wright Medical Australia. This issue has been replicated by the manufacturer in internal tests. Breakage of the tip of the drill during use may lead to the need to remove debris and a delay in surgery. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Wright Medical is advising users that in order to optimize the drilling technique, there will be a modification to the cutting edge of the drill. Users will be contacted for the return and exchange when replacements become available (from November 2017). In the interim, users are advised to apply the drilling force in the axis of the drill (as illustrated in the recall notification).
This action has been closed out on 15/11/2018 |
| Contact Information |
02 9451 2244 - Wright Medical Australia |