| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00865-1 |
| Product Name/Description |
JTS Drive Unit
Item Number: MLE3
All Lots
ARTG Number: 233532 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has received three complaints regarding the JTS Drive Unit. These relate to the potential for utilisation of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device and the potential to select incorrect settings for the extension procedure. As a result, the prostheses in such cases failed to extend as intended.
New labelling is to be provided, and a quick start guide attached to the device, along with revisions to the Limb Lengthening Protocol & Operation Manual to reference these labelling modifications. These modifications/ updates are to clarify the correct orientation in relation to the limb entry point of the device. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is requesting:
1. Users of this Medical Device forward the supplied notice to all those individuals who need to be aware within their organisation;
2. Inspect inventory for the impacted JTS Drive Unit and quarantine it immediately;
3. Contact their local Stryker representative to coordinate the return of any affected product;
4. Complete the supplied “Medical Device Recall Notification Response” form even if they do not have any affected product. Return the form to Stryker by fax on (02) 9467 1325 or electronically via email to recalls@stryker.com;
5. If any affected stock could have been transferred from their hospital to another location, please immediately let them know of this recall and notify Stryker
6. If customers have disposed of any affected units, provide the item and lot numbers of the disposed product to Stryker via email account recalls@stryker.com.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9467 1175 - Stryker |