| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00397-1 |
| Product Name/Description |
iASSIST Validation Tool
Model Number: 20-8011-021-00 Rev M-P
ARTG Number: 205936 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received an increased number of complaints regarding bent or broken Drive Pins of the iASSIST Validation Tool manufactured with drawing Revision M to P. Breakage of the drive pin or drive pin head will lead to the parts having to be retrieved and hence, a delay in treatment.
Only iASSIST Validation Tools with drawing revision M to P Drive Pins are affected (they have a X cross section instead of circular and the Drive Pin head has a recess in the enlarged head). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer Biomet is advising surgeons that the affected products can continue to be used until replacements are available. In the interim, the Knee Surgical Technique (2-Pod Version) (Ref. 97-9001-004-00 Rev 2) and specifically the warning on pages 36 and 37 regarding applying excessive force, should be followed in order to minimize the chances of bending or breakage during use. In addition, surgeons should inspect affected devices before and immediately after use to confirm that the drive pins are not bent or broken. In the event of breakage, the drive pin head will disassemble and therefore surgeons should ensure that both parts are retrieved from the wound.
This action has been closed out on the 23/03/2018. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |