| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00210-1 |
| Product Name/Description |
EBI OsteoGen Implantable Bone Growth Stimulator
Item Number: 10-1320M
Lot Number: 521632
This device supplied via SAS. |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet is conducting a medical device recall for the EBI OsteoGen Implantable Bone Growth Stimulator products due to a lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
The lack of adequate cleaning validation could potentially lead to chemical residuals remaining on the implantable units. The chemical residuals could lead to the potential reactions with patient tissue. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Zimmer Biomet is raising awareness of this issue with implanting surgeons however there are no specific patient monitoring instructions recommended beyond the existing follow-up schedule.
This action has been closed out on 30/10/2018 |
| Contact Information |
02 9483 5426 - Zimmer Biomet |