Health product recall

Sonopet Main Unit, Universal, and Universal Handpiece (2018-03-12)

Starting date:
March 12, 2018
Posting date:
April 3, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66330

Affected products

  1. Sonopet Main Unit
  2. Sonopet Universal
  3. Sonopet Universal Handpiece

Reason

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. Industry-wide IFU update initiated by the FDA. Adding the contraindication: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

Affected products

  1. Sonopet Main Unit

Lot or serial number

All lots.

Model or catalog number

5450-850-000

Companies
Manufacturer

Stryker Medtech K.K.

1131-1 Higashi-naganuma

Inagi,Tokyo-To

206-0802

JAPAN

B. Sonopet Universal

Lot or serial number

All lots.

Model or catalog number

5450-820-000

Companies
Manufacturer

Stryker Medtech K.K.

1131-1 Higashi-naganuma

Inagi,Tokyo-To

206-0802

JAPAN

C. Sonopet Universal Handpiece

Lot or serial number

All lots.

Model or catalog number

5450-840-000

Companies
Manufacturer

Stryker Medtech K.K.

1131-1 Higashi-naganuma

Inagi,Tokyo-To

206-0802

JAPAN