| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00323-1 |
| Product Name/Description |
Instructions For Use (IFU) - Sonopet Ultrasonic Products
Multiple Products
ARTG Numbers:
174349 (Stryker Australia - Electrosurgical unit, ultrasonic/mechanical vibration)
297743 (Stryker Australia Pty Ltd - Ultrasonic surgical system torque wrench, reusable)
298249 (Stryker Australia - Electrode handpiece, electrosurgical, ultrasonic/mechanical vibration, foot-controlled) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
The FDA has recommended that device manufacturers add the following statement to product labelling for ultrasonic aspirators indicated for laparoscopic, open, or gynaecologic surgery:
"Contraindication: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids."
Given this, Stryker is updating the IFU to include this for all Sonopet Ultrasonic Products. All Sonopet Ultrasonic Products manufactured after March 30, 2018 will include an already updated IFU. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Stryker is advising customers that the current IFU is being updated to reflect the new contraindications. Users are to maintain awareness of the updated contraindication to ensure the device is not used for fragmentation, emulsification, and aspiration of uterine fibroids.
This action has been closed out on the 16/10/2018. |
| Contact Information |
02 9467 1111 - Stryker |