Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:22799
Brand Name:Stryker Medtech - I - 47675; Ultrasonic surgical system torque wrench, reusable
Model:
Affected:Torque Wrench 90 Degree, Universal
Software version:
Recalling Organisation:Stryker New Zealand Ltd
515 Mount Wellington Highway
Mount Wellington
AUCKLAND 1060
Contact Information:0800 787 9287
Manufacturer:Stryker Medtech K.K.
Brand Name:Stryker Medtech - IIb - 44750; Soft-tissue ultrasonic surgical system handpiece, foot controlled reusable
Model:
Affected:Small Long Angled Handpiece, Hyper Small Angled Handpiece
Software version:
Recalling Organisation:Stryker New Zealand Ltd
515 Mount Wellington Highway
Mount Wellington
AUCKLAND 1060
Contact Information:0800 787 9287
Manufacturer:Stryker Medtech K.K.
Brand Name:Stryker Medtech - IIb - 36273; Ultrasonic surgical system generator
Model:Sonopet 110V Console with Foot Pedal and Pole, Sonopet 100V Console with Foot Pedal and Pole, Sonopet 230V Console with Foot Pedal and Pole
Affected:
Software version:
Recalling Organisation:Stryker New Zealand Ltd
515 Mount Wellington Highway
Mount Wellington
AUCKLAND 1060
Contact Information:0800 787 9287
Manufacturer:Stryker Medtech K.K.
Issue:Additional information is being added to the Instructions For Use (IFU) for Sonopet® Ultrasonic Products. Ultrasonic surgical aspirator devices use an oscillating tip to cause tissue fragmentation through the delivery of ultrasound energy to target tissue. The potential for tissue dissemination is mitigated, but not completely eliminated, by the use of suction/aspiration. Although FDA is not aware of reports of dissemination or upstaging of occult uterine malignancies related to ultrasonic surgical aspirators at this time, the agency is recommending that all device manufacturers add a contraindication against use for the removal of uterine fibroids.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:11/4/2018
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