Class 2 Device Recall ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch

• Date Initiated by Firm: August 30, 2005
• Date Posted: August 29, 2006
• Recall Status: Terminated on July 13, 2012
• Recall Number: Z-1444-06
• Recall Event ID: 33326
• Product Classification: footswitch - Product Code GEY
• Product: ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch. Used to operate various surgical handpieces.
• Code Information: Serial numbers BBB81339-BBB81407, BBB91192-BBB91194, BBBB91209-BBB91366 and BBB91664-BBB91672.
• FEI Number: 1017294
• Recalling Firm/ Manufacturer: Linvatec Corp.; 11311 Concept Blvd; Largo FL 33773-4908
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.