510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
z-2640-2010

Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan

Stryker Corp. / initiated 2010-07-15 / Terminated / root cause: design
FDA source (opens on fda.gov)

Stryker Instruments Div. of Stryker Corporation began a recall of Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan on . The reason FDA records is "Stryker Instruments acquired the Sonopet Ultrasonic Surgical System from Mutoh co. Ltd on 3/29/2010. Stryker determined that the Sonopet consode did not meet the IEC-60601-1 standard. Stryker decided to recall the...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
z-2640-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Corp.
Product
Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.
Product code
LFL Instrument, Ultrasonic Surgical
Reason for recall
Stryker Instruments acquired the Sonopet Ultrasonic Surgical System from Mutoh co. Ltd on 3/29/2010. Stryker determined that the Sonopet consode did not meet the IEC-60601-1 standard. Stryker decided to recall the Sonopet consode.
Root cause tag
design
FDA root cause
Device Design
Action
The firm to send URGENT MEDICAL DEVICE RECALL NOTIFICATIONS to customers dated 7/15/2010. The customers were instructed to continue to use the device. Stryker technicians were dispatched to replace a board with a new board.
Quantity in commerce
1161
Distribution
Wordwide
Product codes and lots
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