The Recall Desk

FDA (Devices) recall action 65486

Stryker Instruments Div. of Stryker Corporation recalled 3 products on 2013-08-14

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2013-08-14
Critical
0
Units
645

Why these products were recalled

A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply sali

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2013-08-14

    Stryker Recalls Sonopet Ultrasonic Aspirator Consoles Due to Corrosion

    Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working.

    Product
    Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal…
    Category
    Distribution
    22 states
  • HighFDA (Devices)··2013-08-14

    Stryker Sonopet Ultrasonic Aspirator Console Recall for Corrosion Defect

    Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working during surgery.

    Product
    Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery…
    Category
    Distribution
    22 states
  • HighFDA (Devices)··2013-08-14

    Stryker Sonopet Ultrasonic Aspirator Console Recalled for Corrosion

    Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working.

    Product
    Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery…
    Category
    Distribution
    22 states