| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01129-1 |
| Product Name/Description |
Mako THA Application User Guides
Item Numbers: 204863, 207116, 208692, 209711, 210555 and 212026
All Lots and versions
ARTG Number: 223106 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has identified that the THA Application User Guides for specific item numbers did not have the risk control measure included. Five Risk Control Measure were not included in the specific THA Application User Guides:
1. User guide warning to indicate risk of greater trochanter fracture due to insertion of screw.
2. User Manual instruct no to re-capture check-point without re-registration of bone.
3. Statement in the user guide to unscrew the Impaction handle from the implant cup prior to freeing the RIO arm.
4. Training and user guide will indicate insertion of femoral checkpoint may weaken great trochanter.
5. End effector (item number 205020) provides sufficient clearance to mitigate the risk of impingement. Standard OR technique to visually confirm that cuposition is correct. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Inform users of this Recall for Product Correction and forward this notice to all those individuals who need to be aware within your organisation;
2. A Stryker representative will coordinate the swap out of the old version of the User Guides with the new version. The old version may continue to be used until the swap out has occurred;
3. Complete the supplied “Recall for Product Correction Notification Response” form upon receiving the letter to acknowledge you have seen it; and
4. Inform any recipients you may have transferred affected stock to.
This action has been closed out on the 25/09/2018. |
| Contact Information |
02 9467 1175 - Stryker |