Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1444-06

ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch. Used to operate various...

Linvatec Corporation / initiated 2005-08-30 / Terminated

Linvatec Corp. began a recall of ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch. Used to operate various surgical handpieces on . The reason FDA records is "The footswitch may develop a system fault resulting in the self-activation of the handpiece it controls, or it may cause the handpiece to run intermittently or to revert to a default setting". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1444-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Linvatec Corporation
Product
ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch. Used to operate various surgical handpieces.
Product code
GEY Motor, Surgical Instrument, Ac-Powered
Reason for recall
The footswitch may develop a system fault resulting in the self-activation of the handpiece it controls, or it may cause the handpiece to run intermittently or to revert to a default setting.
FDA root cause
Other
Action
Linvatec has issued recall notification to all it''s direct accounts. The mailings were sent by UPS 08/31/2005. Each consignee was requested to return the affected product to Linvatec for a free replacement footswitch.
Quantity in commerce
118
Distribution
Worldwide, including United States and Canada.
Product codes and lots
Serial numbers BBB81339-BBB81407, BBB91192-BBB91194, BBBB91209-BBB91366 and BBB91664-BBB91672.