| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00005-1 |
| Product Name/Description |
SIGMA HP PFJ Cemented Trochlear Implants
ARTG Number: 270733 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, DePuy Orthopaedics, is recalling the SIGMA HP PFJ Cemented Trochlear Implants, which is a standalone component of the partial knee system. This decision is based on elevated revision rates observed as part of the company’s post market surveillance process. Further distribution or use of the affected implants is to cease immediately, and the product is now discontinued. The company recommends that surgeons use alternative implants or consider a total knee replacement. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
DePuy is advising Recipients are requested to return a copy of the completed acknowledgement form as directed in the Hazard Alert and to forward this notice to anyone who needs to be informed.
DePuy Orthopaedics, Inc. is not recommending prophylactic revision in the absence of symptoms. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients who received the affected implants.
This action has been closed out on the 16/11/2018. |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical |