Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0717-03

Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO...

Linvatec Corporation / initiated 2003-01-24 / Terminated

Linvatec Corp DBA Linvatec/Hal began a recall of Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053 on . The reason FDA records is "The Footswitch functions of the left and right foot pedals may be reversed in some units". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0717-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Linvatec Corporation
Product
Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053
Product code
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall
The Footswitch functions of the left and right foot pedals may be reversed in some units.
FDA root cause
Other
Action
The firm telephoned and mailed a Recall Notification letter with response form to all Accounts beginning on 1/24/03. Distributors were asked to subrecall down to the medical facility level. Recalled devices are to be returned to Linvatec for testing.
Quantity in commerce
74
Distribution
Nationwide, worldwide.
Product codes and lots
Units under recall include the following serial numbers: 3582 thru 3681, 3685 thru 3733, 3739 thru 3766, 3768, 3800 thru 3809 (74 units)